State Consumer Disputes Redressal Commission
Arif Mohammed (Minor) vs Parabrhma Speciality Hospital Of ... on 30 September, 2015
Daily Order KERALA STATE CONSUMER DISPUTES REDRESSAL COMMISSION SISUVIHARLANE VAZHUTHACADU THIRUVANANTHAPURAM CC.NO.31/09 JUDGMENT DATED : 30.09.2015 PRESENT SRI.K.CHANDRADAS NADAR : JUDICIAL MEMBER SMT.A.RADHA : MEMBER SMT.SANTHAMMA THOMAS : MEMBER COMPLAINANTS 1. Arif Muhammed, Minor aged 2 years, Rep.by his father, Shajahan, Residing at Mookkasseril, North of Muhindheen Mosque, Kayamkulam 2.M.Mumthas, W/o.Shajahan, Residing at Mookkasseril, North of Muhindheen Mosque, Kayamkulam (By Adv.Sri.T.L.Sreeram) Vs OPPOSITE PARTIES 1. Parabrahma Speciality, Hospital of Research Centre, Ochira, Kollam 2.Dr.Sajikumar.J Consultant Paediatrician, Parabrahma Speciality Hospital, And Research Centre, Oachira, Kollam (By Adv.Sri.G.Jayakumar) JUDGMENT
SRI.K.CHANDRADAS NADAR : JUDICIAL MEMBER This is a complaint filed under section 17 of the Consumer Protection Act. The allegations in the complaint are the following. The second complainant is the mother of the first complainant a minor child. The second complainant got admitted in the first opposite party hospital for delivery on 21.04.2006. She delivered the second complainant on 22.04.2006 at 8.12 p.m. It was a normal delivery and the baby weighed 2.9 kgs at birth. The head circumference of the baby was 37 cms. The delivery was event free and the baby was properly suckling and healthy. The first and second post natal days were also uneventful. On 24.04.2006 at 11.a.m. the first complainant baby was taken to another room for administering a dose of preventive vaccine. After administering the injection the baby was returned to the second complainant. Immediately after entrustment of the baby the second complainant and her husband noticed that the child was motionless and then started vomiting. Thereafter, froth came from the mouth of the baby. Up to the time the baby was taken for vaccination, the baby was active throughout. After vaccination the baby was not suckling for the first time. The husband of the second complainant immediately informed the state of the baby to the nursing staff who in turn informed the second opposite party the doctor. He examined the child and immediately instructed the nursing staff to shift the child to the ICU. The administration of vaccine was done in a separate room by the staff of the first opposite party hospital. Despite shifting the baby to the ICU, the condition of the baby did not improve but only deteriorated and by 10.p.m on 25.04.2006 the condition of the baby became critical. Thereafter, the second opposite party instructed the second complainant and her husband to shift the baby to the institute of child health attached to the Medical College, Kottayam. Accordingly, the baby was shifted to ICH attached to the MCH, Kottayam. The first opposite party never disclosed to the complainants the cause of deterioration in the condition of the baby. It is the doctors attached to the ICH attached to the MCH, Kottayam who revealed that the baby had developed a condition called hypoglycaemia which in the case of the first complainant occurred due to the administration of insulin instead of the preventive vaccine. The doctors at the ICH affirmed that the sudden plunge of sugar level to such an extent can occur only as a consequence of administration of insulin. Evidently the nursing staff of the first opposite party hospital committed grave negligence in administering the drug. Two other new born babies who were taken for administration of vaccine also encountered the same consequences as that of the first complainant. The consequences are so great that the new born babies are affected.
2. Despite the efforts of the doctors at the MCH, Kottayam the baby could not be saved from the adverse consequences of the administration of the wrong drug. The consequences have lead to permanent impairment in the life of the baby. The baby has to take drugs consistently and has to undergo long spells of inpatient treatment which has resulted in mental agony suffering monitory loss and untold hardships to the parents. They had to spend large amount for treatment. The first complainant s father was forced to keep away from his place of work affecting his earning capacity. At present the child is suffering from retarded growth and the baby has not started to speak yet. The movements of the baby are restricted and can sit only with the aid of the parents. The baby cannot walk or get up from bed without the aid of another. The immunity of the child has been afttected. The child is still under treatment and regular medication. The child has to undergo regular check up at least once in a month. Sometimes, the child has to be taken to the hospital two or more occasions in a month and has to be hospitalized. All these results are the direct consequence of the administration of wrong drug by the hospital staff and constitutes deficiency in service and negligence on the part of the opposite parties. Hence they are bound to suitably compensate the complainants. The complainants have claimed Rs.25,00,000/- as compensation for their sufferings and Rs.10,00,000/- towards future treatment and expenses of the child. Rs.25,000/- is claimed as cost of the proceedings.
3. The opposite parties filed joint version. The contentions raised are the following. The complaint is barred by limitation as it is filed three and half years after, the cause of action arose. On the allegations in the complaint technical questions requiring expert evidence arise for decision and it is appropriate that the complainants are directed to approach a civil court for appropriate reliefs. The second opposite party is an unnecessary party as there is no allegation of deficiency in service raised against him. The opposite parties have admitted that the second complainant was admitted in their hospital on21.04.2006 and she gave birth to the first complainant a baby born at 8.12 p.m. on 22.04,2006. The delivery was done with the help of vacuum extraction. The baby cried immediately on delivery and performed normal activities. By 10.15 am on 24.04.2006 hepatitis B vaccine and oral polio vaccine were administered to the baby. As per the prescription of the second opposite party oral polio vaccine two drops and 0.5 ml of hepatitis B vaccine were given to the baby. There was no prescription error or administration error revealed by the hospital records. The allegation that the child was taken to another room at 11.a.m for administering a dose of preventive vaccine is not correct. As per nurses record the baby was given vaccine at 10.15 am. No complaint regarding any untoward condition of the baby was made him 3.p.m when the child had some kind of seizures. Duty doctor Dr.Tennyson attended the baby and immediately shifted the baby to neonatal ICU and the matter was informed to the second opposite party. When examined blood sugar level was 31 mg% which is usually unlikely to cause seizure. Still correction of sugar value was done by administering 10% glucose bolus followed by 10% infusion. No further seizure occurred though the blood sugar level came down to 21 mg% on two occasions. The dose of glucose infusion was increased and later on injection hydrocortisone was added. Seizure due to hypoglycaemia was also ruled out. Laboratory investigations did not reveal any evidence of infection but antibiotics were also started as a safety measure. Finding fluctuation in blood sugar level in spite of all these measures, with the lowest recording at 38 mg% by 7.p.m on 25.04.2006 the baby was referred to the Institute of Child Health Medical College, Kottayam for evaluation as per a detailed reference letter.
4. The opposite parties have denied the allegation that immediately after entrustment of the baby after vaccination, the second complainant found the baby motionless and the baby started to vomit and discharge froth from the mouth, as false and incorporated with ulterior motive. According to the opposite parties no such complaint was ever reported to the staff of the first opposite party or the second opposite party. The second opposite party usually examines patients in OP till 2.p.m or 2.30 p.m. After that he would go for taking lunch. The first untoward symptom in the first complainant occurred at 3.p.m and Dr.Tennison the duty doctor immediately shifted the baby to the NICU. On hearing from Dr.Tennyson that the baby had convulsions the second opposite party rushed to the NICU and took charge of treatment of the baby. The first episode reported was seizure at 3.p.m. and if there was poor feeding, it was not reported to the staff of the first opposite party hospital. If it was reported blood sugar level could have been checked earlier and if required correction of feeding or IV fluids could have been started earlier. If there occurred, any maladministration of vaccine as alleged by the complainants, the symptoms ought to have exhibited the very moment the wrong medicine was given. It is incorrect to say that despite shifting the baby to the ICU the condition only showed deterioration and by 10.p.m on 25.04.2006, the condition of the baby became critical. On the contrary, the condition of the baby had improved with the blood sugar at a higher level and the baby was shifted for further investigation to ascertain the cause of hypoglycaemia at 7.p.m. The first opposite party had informed the relatives of the complainants as to the condition of the baby. The allegation that hypoglycaemia occurred due to administration of insulin instead of preventive vaccine was known only when the doctors at ICH reirterated that sudden plunge of sugar level can occur only as a consequence of administration of insulin is without any basis. It is nowhere mentioned in the discharge summary issued by ICH, Kottayam that administration of insulin was the cause of hypoglycaemia of the first complainant.
5. The allegation in the complaint is made on the layman's impression that hypoglycaemia occurs only after administration of insulin. It is documented in standard text books that hypoglycaemia occurs in five to six percent of all new born babies due to various causes and poor feeding is one of them. Low level of blood sugar can be found in the new born on the third or fourth day. This exactly happened to the first complainant. When insulin is administered subcutaneously, the onset of action is in 30-60 minutes and if the drug is given intramuscularly, the action is much faster. In the case of the first complainant vaccine was given at 10.15 am and the blood sugar level of 31 mg% was recorded only at 3.p.m. In hypoglycaemia caused by insulin, the initial symptom is severe hunger but according to the complainant the first complainant was having poor feeding immediately after the injection whereas it should have been the reverse. The dose of insulin given to diabetic patients is usually around 0.3 units per kg body weight which will amount to less than one unit considering the weight of the first complainant. If the allegation that insulin was given instead of the vaccine is true the blood sugar would have become zero and the baby would have died as 0.5 cc of insulin injection given instead of 0.5 cc of hepatitis vaccine contains 20 units of insulin which would have been 20 times the maximum dose of insulin. It is a massive dose of insulin as far as a new born baby is concerned. 20 units of insulin given to a 3 kgs new born baby is equivalent to 400 units of insulin given to a 60 kgms adult patient. If 400 units of insulin is given to an adult, he will immediately collapse and perhaps die within minutes. So the baby would not have survived even 10 or 15 minutes after the alleged wrongful injection. The gap of almost five hours between the time of injection and the onset of symptoms conclusively disproves the story of accidental insulin injection.
6. It is also impossible to make such a mistake of substituting insulin for hepatitis B vaccine. There is separate immunization room in the first opposite party hospital where lot of infants come and take vaccination on immunization days. There is a separate refrigerator kept in the room which is exclusively meant for storage of vaccines. This room is periodically inspected by the health authorities including the District Immunization officer. No other medicine is kept in that room. Two experienced staff nurses are posted there on immunization days and one nurse from the ward would accompany the relatives of the baby who is being taken to the immunization room. So the chance of giving insulin in the place of hepatitis B vaccine is absolutely nil. The subsequent medical history or the first complainant points out to the possibility of a basic brain problem like developmental or antenatal hypoxia occurring a few days before delivery which is not easy to detect. It is documented in standard text books that the leading cause of neo natal seizure is cerebral ischaemia which may occur in antenatal intrapartum or neonatal periods. In cases were there is prolonged latency between foetal asphyxia insult specialized MRI studies have demonstrated characteristic features of hypoxemic - ischaemic brain injury despite absence of significant acidosis or immediate neonatal depression. The CT scan of the first complainant taken at ICH during neo natal period and subsequently confirm this. Being normal in the first two days of life does not rule out a brain abnormality because many brain abnormalities are manifested at a later age only. Where there is an existing brain damage, the blood glucose has to be maintained at 75 - 100 mg% to provide adequate substrate for the brain. Lower levels may potentiate excitotoxic amino acids and extent the infarct size. This also can produce seizure at a higher level of glucose than what usually produce seizures in normal babies. This could explain why the first complainant had seizures at blood glucose level of 31mg% than the usual less than 20 mg% which can produce seizures. The action of insulin supplied from outside lasts in the body for a maximum 20-24 hours only. It is seen from the discharge summary issued from the Medical College, Kottayam that the baby continued to have low blood sugar levels despite treatment even, up to 02.05.2006 that is 9 days after the alleged mistaken injection.
7. The allegation that two other new born babies who were administered vaccine had also encountered the same complications is false. It is not unusual for the neo natal intensive care unit to house two or more new born babies with apparently similar outward symptoms but the basic pathology as to the cause of their illness may be entirely different. It is admitted in the version that one baby had hypoglycaemia but according to the opposite parties that was in the night only due to faulty feeding habit due to maternal illness. It has no connection with the first complainant's case. If at all the first complainant had developed the complaints alleged it was not due to any negligence or deficiency in service on the part of the opposite parties. The first complainant has not suffered any handicap due to the treatment of the opposite parties. The complaint is devoid of merit and is frivolus and vexatious and is liable to be dismissed.
8. On the allegations in the complaint and the contentions raised by the opposite parties the following points arise for determination.
1. Whether the complaint is sustainable before this commission?
2. Whether the complainants have succeeded in establishing that on 24.04.2006 around 11a.m. the first complainant was administered a dose of insulin instead of hepatitis B vaccine and as a consequence the baby suffered hypoglycaemia and subsequent disabilities?
3. Whether the complainants are entitled to realize compensation, if so what is the quantum?
9. The evidence consists of the depositions of PWs 1 to 4 on the side of the complainants and DWs 1 to 4 on the side of the opposite parties. Exts.P1 to P19 are marked on the side of the complainants and Exts.B1 to B4 (Series) are marked on the side of the opposite parties. After the evidence was recorded arguments were heard.
Point No.1
10. The opposite parties contend that the complaint is barred by limitation and that the complainants ought to have approached the civil court because the adjudication of the complaint involves recording of lengthy evidence as well as decision of complicated issues of fact. The contention that the complaint is barred by limitation is taken, based on the fact that the alleged erroneous administration of insulin instead of preventive vaccine was on 24.04.2006. But the complaint is filed only on 23.12.2009 after a period of about three and half years. But PW1, the father of the first complainant explained that the child was undergoing treatment for the disability caused by the mistaken administration of insulin. In fact, the allegation in the complaint is that the child is still under treatment. The further allegation is that the first opposite party never disclosed to the complainants the cause of deterioration in the condition of the baby. It was the doctors attached to the institute of child health MCH, Kottayam who revealed that hypoglycaemia occurred due to administration of insulin instead of preventive vaccine. So the allegation appears to be that the mistaken administration of insulin came to the notice of the complainants at a later stage and therefore the starting of the cause of action was not on 24.04.2006 but was much later. At any rate, in cases of present nature though the alleged event was on a particular day that is not the only material date and in any case this commission is empowered to entertain a complaint filed even belatedly when there is sufficient cause for the delay. It appears that considering the continuous treatment required for the baby, this is a fit case which can be entertained even if belatedly.
11. As to the contention that the civil court is the appropriate forum to adjudicate such matters, it is pertinent to mention that in so far as the specific allegation is that there was mistaken administration of insulin instead of Hepatitis B vaccine, the incident if proved ipso facto would establish deficiency in service, the adjudication of which is within the power of this commission. The other contentions raised are only ancillary issues. In short, we are inclined to find that the complaint is perfectly maintainable.
Point No.2
12. First complainant, the son of the second complainant and PW1 was admittedly born on 22.04.2006 at 8.12 pm. The delivery was done at the first opposite party hospital with the help of vacuum extraction. It is admitted in the version that the baby cried immediately on delivery and performed normal activities. According to the opposite parties on 24.04.2006 by 10.15 am the first complainant was administered hepatitis B vaccine and oral polio vaccine as prescribed by the second opposite party. The allegation in the complaint is that the baby was taken to another room at 11.am. for administering preventive vaccine. The further allegation in the complaint is that immediately after the baby was entrusted with the second complainant after administering the vaccine it was noticed that the child was motionless, then started vomiting and thereafter froth came from the mouth. The development was immediately informed to the nursing staff. According to the opposite parties there was no complaint regarding the condition of the first complainant made till 3.p.m when the baby had some kind of seizures. Dr.Tennyson the duty doctor immediately attended the baby and shifted the baby to neo natal ICU. The matter was informed to the second opposite party, the consultant paediatrician. He took over the treatment of the baby. The allegation is that after the baby was referred to the institute of child health MCH, Kottayam from the doctors attached to the ICH, the complainants came to know that the baby developed seizures due to hypoglycaemia resulting from mistaken administration of insulin instead of preventive vaccine. So the crucial issue to be resolved is whether there was mistaken administration of insulin instead of preventive vaccine as alleged. For resolving this dispute, oral evidence as well as documentary evidence are available.
13. In resolving this dispute, as discussed later, the time gap between the administration of the drug and the appearance of complications is relevant. In the complaint, though it is alleged that the administration of the drug was around 11.am, the précise time when the baby was returned to the parents after vaccination is not stated. But as PW1the father of the child deposed that the child was returned to them within 5 - 10 minutes after administering preventive vaccine. He explained that symptoms like froth coming from the mouth were observed by about 2.p.m and immediately he informed the nurse about the development. So going by the case of the complainants the illness started around three hours after the administration of the drug. According to the opposite parties the symptoms were reported to the opposite parties after about five hours. Ext.B2 op records relating to the baby kept in the opposite party hospital confirms the development as mentioned in the version. The complainants have also produced the treatment records relating to the baby subsequently in several other hospitals such as ICH, attached to MCH, Kottayam. Paediatrics Department of Aleppey Medical College and Sree Chitra Institute of Medical Sciences, Thiruvananthapuram. These records are produced to prove that the child suffered disabilities as a consequence of mistaken administration of insulin instead of preventive vaccine. It is sufficient to say that as at present the child is not fully healthy and requires constant medical attention but whether the cause was mistaken administration of insulin can be determined only with reference to the entire evidence recorded in this case, in particular, the oral evidence of expert witnesses relating to the effect of mistaken administration of insulin. The possibility of happening that mistake and the consequences are also relevant.
14. PW2 is the professor and head of department of paediatrics Medical College, Thiruvananthapuram. She explained that the behavior of a normal child at birth would be to suckle and be active. Hypoglycaemia would not occur in healthy babies after vaccination. By hypoglycaemia it is meant that the glucose level in the blood comes down. In the case of a new born baby when the glucose level falls below 40 mg%, it can be said that the baby is having hypoglycaemia. To the suggestion that in cases of acute hypoglycaemia the child would become motionless would vomit and froth would come from the mouth, PW2 answered that vomiting is not common. Motionlessness is also not that much common. The child would be tired and at the initial stage giddiness and fits like condition may develop. Ordinarily hypoglycaemia is seen more in premature babies and underweight babies. But if the mother during pregnancy had suffered from illness or the mother had difficulties during giving birth to the child or the child suffered from birth asphyxia and if there is some birth defect or metabolic disorder, then also hypoglycaemia is likely to develop. If the child has hypoglycaemia at birth it is not necessary that the child should exhibit the symptoms immediately after birth. The exhibition of symptoms is dependent on the quantity of glucose in the blood of the child supplied by the mother, the birth weight of the child and whether there is other illness for the child. Soon after birth the baby would cry and in case of failure that would affect supply of oxygen to the brain and this condition is called birth asphyxia.
15. PW2 further explained that if glucose level in the blood falls marginally, no disability would be caused but if the level of glucose falls considerably or the condition persists for a long time, disabilities such as retardation in growth and development of intelligence, inability to stand or walk etc can happen. With reference to the records produced PW2 deposed that during pregnancy no abnormality to the child was detected by the ultra sound examination. PW2 with reference to Ext.P5 explained that after birth the baby was suckling well and exhibited good activities on day one, but developed several episodes of uprolling of eyes on 24.04.2006 noon. Further the baby developed hypoglycaemia and suckling became poor.
16. PW2 explained that there is specific instruction not to keep vaccines and medicines like insulin in the same place. The reason is vaccines should be kept at specific temperature. If medicines are kept in the same refrigerator, there would be frequent use of the refrigerator leading to variation in temperature. If three new born babies developed acute hypoglycaemia after vaccination that is never an ordinary incident. The normal dose of hepatitis B vaccine given to a new born baby is 0.5 ml. Hepatitis B vaccine is given as intra muscular injection. In such cases, the action of the medicine would be rapid compared to subcutaneous injections. Insulin is ordinarily administered as subcutaneous injection.
17. PW2 affirmed that if 0.5 ml of insulin is given to a three days old baby, it would be equivalent to20 units of insulin. If 0.5 ml of insulin is given to a new born baby, it would reduce the blood glucose level to such an extent that the survival of the baby is very promote.PW2 did not deny the suggestion that 0.5 ml of insulin is a massive dose and is capable of reducing the blood glucose level of a baby to zero within half an hour. If an ordinary person is administered with insulin its effect would last in the body 6 - 8 hours. If insulin is administered to a baby it would not cause fluctuations in the glucose level for 5 - 6 days.
18. According to PW2 hypoglycaemia is a common complaint found in new born babies. It is often a metabolic problem caused by circumstances like premature birth under weight certain illness to the mother during pregnancy congenital defects metabolic disorders etc. Persistent hypoglycaemia can be caused by poor feeding congenital disorders, injections, defects in brain and heart, endocrine abnormalities and enzyme deficiencies.
19. With reference to Ext.P7, PW2 explained that umbilical cord was coiled around the neck of the baby during pregnancy and the baby had to be taken out by vacuum extraction. This could have caused defects in the brain. Due to such a condition it is likely that oxygen supply to the brain would be reduced. In re-examination PW2 admitted as correct the suggestion that upon administration of 0.5 ml of insulin if immediately it is noticed and remedial medicines are given, it is likely to cause serious problems like retardation in growth. Vacuum extraction of a baby is not so common a procedure now.
20. The evidence of PW3 and DW2 supplements or affirms the evidence of PW2 in many aspects PW3 is working as a gynaecologist. He explained that as per Ext.B3 it is not recorded that till third day the new born baby had any illness or difficulty. Hepatitis B vaccine would be administered either immediately after birth or on the third day. As per EXt.P5, the baby was showing normal activities and suckling well.
21. DW2 is the second opposite party the paediatrician who attended the first complainant. He took over the treatment of the baby at 3.p.m on being informed of the complications .He admitted that he prescribed vaccination for the baby on 24.04.2006. This can be seen from Ext.B2 (a). He further deposed that the umbilical cord of the baby was coiled around its neck during pregnancy. But the baby had no illness up to 43 hrs after birth. He was in charge of the treatment of the baby for one day after the baby developed illness. He reireterated the view of PW2 that hypoglycaemia develops when the blood sugar level falls below 40-45 mg %. The clinical symptoms of hypoglycaemia are the failure of the baby to suckle, and baby's failure to cry. When the sugar level is very low, fits would develop and there would be sweating from the forehead. This happens when the sugar level falls below 20 units or the hypoglycaemia prolongs for a considerable time. The reasons for developing hypoglycaemia mentioned by PW2 are reireterated by DW2 also. As far as this baby was concerned it showed no symptoms of hypoglycaemia at the time of birth. The vaccination room is under the control of DW2. During the subsequent examinations no illness that caused hypoglycaemia was found. He explained that blood tests were done to see whether there was any infection in the child. DW2 admitted that apart from the first complainant the new born baby of PW4 also developed hypoglycaemia and according to him that was due to meningitis and that baby was treated in the opposite party hospital itself.
22. So the evidence of PWs 2 & 3 and DW2 explains when hypoglycaemia can occur in new born babies and the consequences. Before adverting to the several arguments raised by the opposite parties to rule out the possibility of mistaken administration of insulin instead of hepatitis B vaccine, it may also be mentioned that PW4 was examined to prove that three new born babies taken to immunization room around the same time to administer vaccines developed hypoglycaemia and this according to the complainants was due to administration of insulin by mistake instead of hepatitis B vaccine. PW4 gave evidence in support of the case of the complainant but according to the paediatrician who treated the babies hypoglycaemia in that child developed due to a different reason namely meningitis. Ext. B4 Op records relating to the baby of PW4 are produced by the opposite parties. But the possibility of mistaken administration of insulin still remains to be adjudicated with reference to the entire circumstances available in this case.
23. The circumstances highlighted to urge that mistaken administration of insulin was not the reason for the complications are the following. Relying on the evidence of DW3, the pharmacist in the opp.party hospital DW4, the nursing superintendent in the first opp.party hospital and to some extent the evidence of DW2, the paedeatrician, it is pointed out that there is a separate immunization room and vaccines are stored in a separate refrigerator entirely away from regular medicines. In fact, vaccines are required to be stored at a particular temperature and the regulations require that vaccines are separately kept and administered. But human error can occur at any time and human actions are not free from errors, however, serious may be the precautions taken. So it is desirable that the other circumstances highlighted are considered in taking a decision as to whether mistaken administration of insulin instead of hepatitis B vaccine happened as a matter of fact.
24. One of the main circumstances advanced by the opposite parties is that once administered the action of insulin starts within 30-60 minutes and 0.5 ml of insulin administered in a baby of 3kgs is massive dose sufficient to lower the blood glucose level to 0 mg% which is highly fatal. While PW2 affirmed this it was explained during re-examination that if there was mistaken administration of insulin and immediately corrective measures are taken, the baby is not likely to die but would survive with disabilities such as retardation in growth. So the immediate question is whether as a matter of fact mistaken administration of the drug came to the notice of the opposite parties and remedial measures were taken. In this regard the allegation in the complaint is that on 24.04.2006 at about 11 a..m. the baby was taken to immunization room to administer a dose of hepatitis B vaccine and when returned to the second complainant after injection the baby was found motionless and started to vomit . Thereafter froth came from the mouth of the baby. Immediately, the matter was informed to the nursing staff. But the oral evidence of PW1, the father of the baby who was admittedly present on the occasion does not support the case alleged in the complaint. He categorically deposed as referred to earlier that the baby was taken of the immunization room at about 11.am. on 24.04.2006 and the baby was returned to the mother after giving preventive medicine within 5 - 10 minutes . According to him, symptoms of illness was shown by the baby by about 2.p.m. So there was a time lag of about three hours and neither the doctors of the opposite party hospital or the nursing staff got no opportunity to take immediate remedial action. This time lag according to the opposite parties is more than five hours and the treatment records of the baby kept in the opposite party hospital are also to the same effect. So it is important that had there been mistaken administration of insulin ample time was available for the insulin to act and lower the glucose level to fatal limits. So this is a circumstances that points to the absence of mistaken administration of insulin.
25. Another circumstance relied on by the opposite parties is the allegation in the complaint that immediately after the baby was returned to the parents after administering preventive vaccine, the child was found motionless and not suckling. According to the opposite parties if insulin is administered the initial response would be hunger not absence of feeding before finally the patient becomes lethargic. This may be a minor circumstance but the circumstance that subsequently also the child suffered from bouts of hypoglycaemia is relevant. The expert evidence available is that once insulin is administered the action of that particular dose would last 20-24 hours and if the baby or any person remains healthy, there would be no further action of the insulin already administered. But the records available show that on subsequent occasions also the child suffered from hypoglycaemia and there are indications of brain disorder as possible cause of hypoglycaemia.
26. The allegation in the complaint is that on the next day, that was on 25.04.2006, the condition of the baby became critical and as instructed by the second opposite party the baby was shifted to the institute of child health attached to the MCH, Kottayam. So the opposite parties did not treat the baby after 25.04.2006. But Ext.B4 series of diagnostic results showed wide fluctuation in blood sugar levels of the baby. On 26.04.2006 the blood sugar level was 52mg%.On 25.04.2006 random blood sugar in the baby was 103 mg/dl. On 30.04.2006 random blood sugar was 44 mg/dl .On 29.04.2006 random blood sugar was 39mg%. On 01.05.2006 the random blood sugar was 42mg/dl .On 02.05.2006 the random blood sugar was 43mg% and on 03.05.2006 random blood sugar was 62mg%. Variation in the level of blood sugar may happen even in ordinary course depending upon the feeding habits. But the relevant fact is that when CT scan brain was taken, features suggestive of HIE was shown by the baby as seen from an undated scan result found among Ext.P4 series of documents It is seen from Ext.P5 that the child was admitted in the institute of child health MCH, Kottayam, on 25.04.2006 and the diagnosis was Term/AGA/NNS/? hypoglycaemia. So hypoglycaemia was suspected Ext.P7 is the discharge card relating to a subsequent admission of the baby in the said institute. The diagnosis then made was HIE or seizure disorder. Ext.P8 is the health record of the baby issued from the Medical College Hospital, Alappuzha. The diagnosis seen made is early myoclonic Encephalopathy. It is seen from Exts.P10 and P11 that the baby was admitted in the Medical College, Kottayam on 12.03.2007. The CT scan of brain dated 13.03.2007 is among Ext.P11 series of documents and the impression in the scan was gross cerebral atrophy. It is seen from Ext.P15 issued from Sree Chithra Thirunal Institute for Medical Sciences, and Technology, Thiruvananthapuram that on admission there, the diagnosis was neuro degenerative disorder right upper lobe. Query was raised whether it was a seizure induced repression.
27. So the subsequent treatment records point to brain disorder as a possible reason for hypoglycaemia. The immediate question is whether there is evidence to prove that the brain disorder was the result of mistaken administration of insulin as the cause of hypoglycaemia. While there is evidence to indicate that during pregnancy the umbilical cord of the baby was coiled around its neck and vacuum extraction of the baby was made, the only available circumstance is that till the third day the baby had not exhibited any illness but the expert evidence available is that even an inherent brain problem can express itself later. Regarding the possibility that the brain disorder was insulin induced there is absolute lack of evidence and none of the experts was asked to explain such a possibility.
28. So on appreciating the evidence as a whole the possibility of having administered insulin instead of hepatitis B vaccine as alleged appears to be not the probable cause of the problems of the baby. So the complainant has not succeeded in establishing deficiency in service on the part of the opp.parties. The point is found accordingly.
Point No.3
29. The evidence reveals that the first complainant baby is under several disabilities and requires continuous treatment. However, in view of the finding on point no.2 that deficiency in service on the part of the opposite parties is not established as the cause of the same, it is unnecessary to decide the quantum of compensation payable to the complainants.
In the result, the complaint is dismissed but without costs.
K.CHANDRADAS NADAR : JUDICIAL MEMBER
A.RADHA : MEMBER
SANTHAMMA THOMAS : MEMBER
APPENDIX
List of witnesses for the complainants
PW1 - A.Shajahan
PW2 - Dr.Lalitha Kailas
PW3 - Dr.Binu Thomas
PW4 - Vineetha.K
List of witnesses for the opposite parties
DW1 - Sivasankaran.P.M
DW2 - Dr.J.Sajikumar
DW3 - Sajinadhan
DW4 - Mrs.Rema Prasad
List of Exhibits from the side of complainants
Ext.P1 - Photocopy of birth record issued from the
opp.party hospital
Ext.P2 - Photocopy of treatment card dated 10.10.2005 issued
from the opp.party hospital
Ext.P3 - Copy of discharge card issued from the opp.party
hospital
Ext.P4 - Copy of discharge card issued from Institute of Child
Health Medical College, Kottayam
Ext.P5 - Copy of test results conducted at Amala Diagnositc
centre 26.04.2006
Ext.P6 - Copy of CT scan report issued from Venus Diagnostics
Ltd
Ext.P7 - Copy of test results dated 28.04.2006 issued from
Amala Diagnostic Centre, Kottayam
Ext.P8 - Copy of Microbiology test result dated 28.04.2006 issued
from Amala Diagnositc Centre, Kottayam
Ext.P9 - Copy of biochemical test result dated 29.04.2006 issued
from Amala Diagnostic Centre, Kottayam
Ext.P10 - Copy of test results dated 30.04.2006 issued from
Mediline Laboratories, Ettumanoor
Ext.P11 - Copy of blood culture report dated 30.04.2006 issued from
Doctors Diagnostic Centre, Kottayam
Ext.P12 - Copy of test result dated 01.05.2006 issued from the
Mediline Laboratories, Ettumannor
Ext.P13 - Cop of test result dated 02.05.2006 issued from the Amala
Diagnostic Centre, Kottayam
Ext.P14 - Copy of test result dated 03.05.2006 issued from the
Amala Diagnostic Centre, Kottayam
Ext.P15 - Copy of discharge card dated 10.06.2006 issued from the
Institute of Child Health Medical College Hospital, Kottayam
Ext.P16 - Copy of C.T.Scan report dated 13.03.2007 issued from the
Venus Diagnostic Ltd, Gandhinagar.P.O Kottayam
Ext.P17 - Copy of discharge card dated 07.04.2007 issued by the
Institute of Child Health, Medical College, Kottayam
Ext.P18 - Copy of discharge card dated 20.10.2007 issued from the
Institute of Child Health Medical College, Kottayam
Ext.P19 - Copy of referral letter issued by Dr.C.V.Roy dated
08.11.2007
List of Exhibits from the side of opposite parties
Ext.B1 - Authorization letter
Ext.B2 & Ext.B2 (a) - Medical record
Ext.B3 & Ext.B3 (a) - Medical record
Ext.B4 & Ext.B4 (a) -Medical record
K.CHANDRADAS NADAR : JUDICIAL MEMBER
A.RADHA : MEMBER
SANTHAMMA THOMAS : MEMBER
Be/
KERALA STATE
CONSUMER DISPUTES
REDRESSAL COMMISSION
SISUVIHARLANE
VAZHUTHACADU
THIRUVANANTHAPURAM
CC.NO.31/09
JUDGMENT DATED : 30.09.2015
Be/