MANJU vs C M O St Stephens Hospital

THIS is a most unfortunate case. The unfortunate child of unfortunate parents was born on 14.8.1999. He is almost 6 years of age. He was born with following horrible congenital abnormalities: (1) Depressed nasal bridge. (2) Cataract of the Right Eye. (3) Cleft lip, cleft palate. (4) Absent Right Thumb. (5) Right Radius (forearm bone) aplasia. (6) Malformed Right Ear.

THIS appeal arises from allegation of medical negligence on the part of the respondent -Hospital inasmuch as that the appellant was expecting pre -mature delivery after having undergone three consecutive abortions and in spite of the Torch Test performed upon her being positive and clinically suspected to have Intra Uterine Growth Retardation (IUGR), the respondent did not explain that there was a possibility of a child being born with certain congenital abnormalities and, therefore, she consented to have a child. The complaint of the appellant seeking damages and compensation on account of medical negligence and deficiency in service as contemplated in Section 2(1)(g) of the Consumer Protection Act was dismissed vide impugned order dated 26.4.2001 on the ground that the appellant had failed to make it a case of negligence on the part of the respondent and in view of the affidavit of the respondent that the appellant was duly explained about the child may born with certain congenital abnormalities and, therefore, the respondents were not liable to pay damages or compensation.

THROUGH this appeal the impugned order has been assailed mainly on the ground that the respondent had manipulated and fabricated the record and filed affidavit subsequently whereas the original records at the time of examination of the appellant did not have any endorsement that the risk of the IUGR was explained and that appellant was clearly informed that there was a possibility of child being born with certain congenital abnormalities.

THE short history of facts, relevant for our purpose, is like this. On 6th of January 1999 the appellant visited the hospital of the respondent No. 1 for consultation as she became pregnant for the 4th time though her three earlier pregnancies did not mature. On examination she was advised to have ultra -sound which was conducted on the same day and was repeated on 18th January, 1999. According to the appellant she was told that she has a normal pregnancy and, therefore, prescribed to take certain medicines. She was again advised for ultra -sound which was conducted on 19th May, 1999, 16th June 1999, 11th August, 1999 and in all the ultra -sounds the report was that the child was normal in the womb. On 11th August, 1999 the appellant was admitted in the hospital on the pretext that she was expecting a pre -mature delivery. On 13th August, 1999 some medicines were administered in the vagina and a male child was born on 14th August, 1999 with the aforesaid physical defects though the appellant noticed that the upper lip of the child was cut, the upper portion of the mouth over the tongue was having some injuries, right ear was injured, while the right hand was totally chopped. The child was kept in the nursery ward for few days and was ultimately discharged on 16th August, 1999. As against this, respondents version is lenghty and like this. That she had tested positive for Torch Test which is clearly indicative of possibility of birth of a baby with congenital abnormalities and in view of the past history and symptoms all of which are suggestive of a threatened abortion she was admitted for observation, investigation and medication and the ultra -sound done on 6th January, 1999 confirmed the intra uterine pregnancy and since it did not identify a foetal cardiac activity for which she was advised second ultra -sound. The third ultra -sound examination conducted on 18th January, 1999 also showed intra uterine pregnancy of seven weeks with a foetal pole and since the pregnancy parameters were less by one week as compared to period of gestation, blood test was carried out. The said test showed a significantly positive result for Torch Test. The Torch Test was positive for Rubella and Herpes Simplex pointing out the possibility of the birth of a boy with congenital abnormalities.

FURTHER that the risks of positive Torch Test were explained to the appellant but she chose to continue with the pregnancy and, therefore, another ultra -sound examination was done on 19th May, 1999 which showed 23 weeks plus 5 days old live foetus with no probable gross anomalies incompatible with life. She was admitted in the hospital on 16th June, 1999 in view of pedal oedema (swelling in feet), albuminuria (urine problem) and oliguria (less urine). However, the condition of the appellant improved on account of the treatment and, therefore, she was discharged on 18th June, 1999. She again came to the respondents hospital on 11th August, 1999 when she was having pregnancy of 37 -38 weeks because of having been clinically suspected to have Intra Uterine Growth Retardation. She was admitted in the hospital on the same date and again ultra -sound examination was conducted. Ultra -sound again confirmed IUGR. It was after explaining the risks of IUGR to the appellant in clear terms that there was the possibility of a child being born with certain congenital abnormalities she consented to deliver the child and in view of the risk of IUGR, labour was induced. Result is before us.

IN nutshell the contentions of the Counsel for the respondent boil down to following defences: (i) Having regard to the medical history (three spontaneous abortions, treatment at ESI Hospital for recurrent abortions, testing positive for Rubella and Cytomegaloverus in October 1998), the doctors correctly apprehended an infection and, therefore, recommended the Torch test and an ultra sound. (ii) The Touch Test was positive for Rubella and Herpes Simplex. Since Rubella can result in congenital anomalies, the risk of Rubella positive was explained to the patient (22.1.1999). The patient was also aware of the risk of Rubella positive as she had tested positive for the same earlier as well. (iii) However, the patient elected to continue the pregnancy, presumably on account of the fact that she had already three spontaneous abortions and had thus lost three children. The risk was also explained on 16.6.1999 and 11.8.1999. (iv) The birth of a child with congenital anomalies was not the result of any error or lack of care. The treatment given was as per accepted medical practices. No specific error in the line of treatment has been pointed out. (v) The patient was extremely uncooperative and left the hospital against medical advice on 9.1.1999 and 16.8.1999. The parents also did not permit the child to be treated and took him away even though a number of anomalies are correctable. In nutshell substantial contention is that applying the aforesaid tests it is evident that the hospital and its doctors have not committed any error, much less an error no doctor of reasonable competence shall commit.

THOUGH there are serious allegations of manipulation and interpolation of documents which were with the O.Ps. as the record of the patient on the medical aspect and the liability of the O.Ps. arising out of negligence from the deficiency in service, the Counsel for the appellant has made the following contentions: (i) Aforesaid so called congenital anomalies are easily detectable by ultrasound as demonstrated in table 1 of literature Ultrasound and Fetal Diagnosis of Perintal Infection, which has been relied upon by the Counsel for the O.Ps. (ii) That when the respondent was taking undertaking of the husband of the patient at almost every occasion when the patient visited the hospital it is not understandable why it did not take the undertaking by explaining the risks of Rubella and Herpes Simplex. (iii) Falsehood as to the claim of the respondents that the appellant has visited only four times is demonstrated from the record that shows that the patient visited the hospital as many as on 25 occasions and this is amply clear from the record from pages 20 -31. (iv) In the sixth history sheet the complainant had undergone treatment at ESI hospital and there she had been tested positive for the Torch Test but the same fact has not been mentioned in the discharge slip dated 9.1.1999.

THUS , according to the Counsel for the appellant the respondent was grossly negligent in not explaining the risks involved in Rubella and Herpes Simplex and in spite of knowing the risks the respondents forced or persuaded the appellant to have birth of a child and secondly that injuries at the time of birth showed bitter and cruel negligence during the birth of the child. Since the child has congenital defects and appellant has to live with no other alternative but to carry or bear with the child the whole life and the child has also to carry this burden in full of his life. Though at the time of filing the complaint compensation of Rs. 5 lakh was sought for but now the child has grown up and of 6 years old and specially suffering from depressed nasal bridge, cataract of the right eye, cleft lip, cleft palate, absent right thumb and malformed right ear itself is a horrible that the amount of compensation of Rs. 5 lakhs is not a compensation at all.

AS is apparent from the aforesaid conspectus of facts the solitary question that calls for determination is whether the appellant was explained that there was possibility of a child being born with certain congenital abnormalities in view of the Torch Test and IUGR test being positive. The onus to prove lay heavily upon the respondent. The crucial document produced by the respondent in this regard is Out Patient Department Record No. 393994. The perusal of this record shows that the appellant had visited respondent -hospital on four occasions. First time she visited on 6.1.1999 and the ultra -sound conducted could not identify the foetal node i.e., fetal heart beat. The patient was advised admission and was actually admitted on that date. She was admitted on the basis of the previous history of three consecutive abortions, positive Torch Test for Rebulla and CMB. She was admitted for treatment along the lines of certain operations after ultra sound report and USG for foetal liability. On 9.1.1999 the husband of the patient took her away against medical advice and writing was obtained from him to the following effect: '' I am taking my patient against medical advice and if anything happens to the patient I am responsible for that.''

THE patient was again taken to the OPD on 18.1.1999. She was again subjected to ultra -sound which showed pregnancy of seven weeks and the pregnancy parameters were less by one week as compared to the period of gestation. Again Torch Test was carried on that date and it again turned out to be positive. She was advised bed rest. On 22.1.1999 she again visited the hospital as by that date the report of Torch Test was received. There is an endorsement made on that date in the O.P. record to the following effect: ''Risk Rubella positive explained.'' She again visited the O.P.D. on 5.3.1999 and was prescribed certain medicines. Her next visit to the hospital was an 16.6.1999 with a complaint of pedal oedema (swelling in feet), albuminuria (presence of albumin in urine) and oliguria (less urine) and she was admitted in the hospital on that date. On that date risk of protenuria and oedema of feet was also explained to the patient. On 11.8.1999 she again came to the hospital for checkup. At that time she was 37 -38 weeks pregnant. She was admitted in the hospital and ultra -sound again confirmed she had IUGR. An endorsement was made on the OPD card to the following effect: ''Effects of rubella positive on the fetus to be explained. Risk of IUGR to be explained.''

THERE is another record in the progress notes on 11.8.1999 where the endorsement that risk IUGR has been explained to the husband of the patient and his signatures has been obtained underneath. Child was born on 14.8.1999 with above referred congenital defects. On 16.8.1999 the husband of the patient took the patient and the baby from the hospital against medical advice. Endorsement under the signatures of the husband of the patient was obtained by the hospital. There is another note made in the birth information chart at 5.40 a.m., which is to the following effect: ''I am not willing to keep my baby in nursery. All congenital malformation explained to me. Not willing for any active intervention if any thing happens to the baby I will be responsible.''

ON the same day at about 6.10. a.m. i.e., hardly after half an hour another endorsement was obtained from the husband of the patient showing that he was willing to keep the baby in the nursery but without any active intervention and he will pay for the nursery charges. ''I am willing to keep my baby to nursery. All congenital anomalies explained to me. No active intervention to be done for the baby. I will pay the nursery charges also.'' In the evening he again told the hospital that he was taking the baby against medical advice. An endorsement was obtained to the following effect : ''I am taking patient and baby from St. Stephen Hospital against medical advice.'' On 16.8.1999 another endorsement was made on the chart that the patient does not want any investigation on the child and wants to take the child home. He left the hospital against medical advice.

THE fetal retardation and malformation are not shown and projected in the ultra -sound as in the instant case no such indication was given in the first ultra -sound but it was the second ultra -sound which effected the heart beat but the growth retardation was effected on the third ultra -sound. In this regard following medical literature is relevant: (i) An article titled Ultra -sound and Fetal Diagnosis of Prenatal Infection by Judge P. Crino, MD, The University of Texas -Houston Medical School, Houston, Texas - ''Limitation of Ultra -sound - The utility of ultra -sound in the setting of fetal infection is limited by several factors - (1) Most infected fetuses are sonographically normal. Thus, although a normal fetal anatomy survey can provide some reassurance for the patient at risk for fetal infection, it cannot predict a normal outcome. (2) Ultra -sound findings may change with time. A fetus may demostrate no abnormalities or only subtle findings on initial evaluation and subse -quently manifest obvious multiple organ system involvement. This is illustrated in a report by Stein et al of a fetus with a solitary hepatic calcification in the second trimester who later developed multiple hepatic calcifications and microcephaly and eventually died of congenital CMV infection. Some sonographic findings also may improve as the pregnancy progresses. What Morse et al described a case of congenital CMV in which the initial second trimester findings of marked fetal ascites, cardiomegaly, hepatosplenomegaly, and placentomegaly gradually resolved; mild ventriculomegaly and oligohydramnios, neither of which had been present initially, developed in the third trimester. (3) Predictive value depends on disease prevalence. The predictive value of any diagnostic test depends on the prevalence of the disease in the population studied; as the prevalence increases, so does the predictive value. Almost all published studies of ultra -sound in fetal infection are limited to populations with high fetal infection rates, such as patients with reactive serologic tests for syphilis or toxoplasmosis secroconversion during pregnancy. Although ultrasound demonstrates impressive predictive values in this setting, one should not expect such results in a low risk population. (4) The high termination rate in most studies precludes evaluation of prognostic significance. The majority of patients with ultrasound findings of fetal infection reported in the literature elected pregnancy termination; thus, prenatal findings cannot be correlated with infant outcome. Limited data suggest that infected fetuses with morphologic abnormalities on prenatal ultrasound may have a worse prognosis than those who are sonographically normal.'' (ii) An article under the title ''Clinical Genetics by Elaine H. Zackai, Nathaniel H. Robin giving medical information with regard to birth defects - ''Birth defects are commonly encountered by any physician who cares for pediatric -age patients. Studies have shown that 1% to 3% of new borns have a major congenital anomaly that will affect their quality of life. In 1988 the Centres for Disease Control reported that birth defects were the leading cause of infant mortality, the primary cause of 8160 (20.1%) infant deaths, and a contributing cause in 1000 more. In addition, such patients account for a disproportionate number of hospital visits, intensive care unit (ICU) admissions and overall use of health care resources. Studies have shown that approximately 50% of all pediatric patients admitted to the hospital had a disorder with some genetic component, and 25% to 30% had a birth defect. In neo -natal ICUs, genetic disorders account of 10% of admissions and 23% to 35% of deaths. For pediatric ICUs, 6% of patients have a genetic disorder. Many if not all children with a congenital anomaly require surgical care at some juncture in their lives, often in the neo -natal period on an emergent basis. Because the surgeon is frequently the first physician to care for the patient, it is crucial for these physicians to have a framework for evaluating the child with a congenital anomaly to know which patient should be evaluated by a clinical geneticist. The care of a child with a straight -forward congenital anomaly does not require special consideration but in questionable cases a collaborative effort amount many physicians, including the clinical geneticist, is required to unify seemingly unrelated problems under one diagnostic heading. Genetic evaluation may identify associated anomalies or a syndrome that needs to be investigated. Once an accurate diagnosis is reached, the natural history of the condition can be clarified. Making a diagnosis may answer the following questions: Will new problems, such as specific learning disabilities, surface as the child gets older? Is there an increased risk for malignancy? By familiarizing themselves with the problems associated with various genetic disorders, surgeons can screen for and address these problems at the first sign. Also in planning appropriate therapy, surgeons need to know the prognosis of certain genetic disorders. The geneticist should discuss the recurrence risk, the change of having another child with a similar problem, and the availability of prenatal diagnosis with the family. In addition, the geneticist often becomes a valuable long -term resource by placing the family in contract with parents of children with similar probems and support and advocacy groups.''

LET us deal with the case in the light of facts as projected by the respondent -hospital. From the record there is not an iota of indication as to what kind of risks or what kind of deformities the child will suffer from. Mere simplicitor endorsements that the risks of Rubella explained to a semi -literate poor person is meaningless. Even a highly educated person may not know the kind of risks of Rubella and Herpes Simplex. Unless and until the nature of deformities had been explained in detail, endorsement showing risks of Rubella and Herpes Simplex explained was negligence and deficiency of highest order. Merely because the mother of the child had earlier 2 -3 consecutive abortions would pine for a child, it was still the duty of the respondent hospital to write and make the note in the medical record as to the nature of risks involved and endorsement that these have been explained in the language the patient understands. To expect from a layman or even educated person to know the meaning of Rubella and Herpes Simplex is too much. In common parlance whenvever a medical professional or the person operating the patient makes an endorsement of the risks of the operation have been explained to the patient or his relative, it ordinarily means risk of death but not the kind of risks involved as were involved in the instant case. Here is a child who was allowed to be born with such deformities like depressed nasal bridge, cataract of the right eye, cleff lip, cleft palate, absent right thumb, right radius (forearm bone) aplasia and malformed right ear. If we believe the record of the respondent -hospital and the doctors making endorsements that aforesaid risks were explained that a child will be born with such deformities but it is difficult to accept that still the appellant had agreed for the birth of the child.

THUS if the operating doctor or the medical professional does not explain to the patients as to the nature of risks involved in the operation or in the process of treatment and merely makes a simple or general endorsement that the risks have been explained which in normal course is risk of death the doctors or the hospital are squarely guilty of medical negligence amounting to deficiency in service as contemplated under Section 2(1)(g) which means any fault, imperfection, shortcoming or inadequacy in the quality, nature and manner of performance which is required to be maintained by or under any law for the time being in force or has been undertaken to be performed by a person in pursuance of a contract or otherwise in relation to any service.

NO medical literature of any kind can come to the rescue of the respondent hospital as doctors were highly negligent and deficient in not explaining the risks on the actual and factual aspects as to what kind of deformities the child would have. It is again very disturbing that a doctor who knew about the actual risks involved in the Rubella and Herpes Simplex still allowed a child to come in this world and making not only the child but also his parents suffer incessantly throughout their life by incurring huge expenses in bringing up the child who is likely to suffer for many diseases due to these deformities. Next, we come to the medical negligence during the operation for birth of the child. As to the action for negligence against a Surgeon, there is a following unvarying unanimous view: ''Laxman Balakrishna Joshi v. Trimbak Bapu Godbole & Anr., 1969 (1) SCR 206 - The duties which a doctor owes to his patient are clear. A person who holds himself out ready to give medical advice and treatment impliedly undertakes that he is possessed of skill and knowledge for the purpose. Such a person when consulted by a patient owes him certain duties, viz., a duty of care in deciding whether to undertake the case, a duty of care in deciding what treatment to give or a duty of care in the administration of that treatment. A breach of any of those duties gives a right of action for negligence to the patient. The practitioner must bring to his task a reasonable degree of skill and knowledge and must exercise a reasonable degree of care. Neither the very highest nor a very low degree of care and competence judged in the light of the particular circumstances of each cases is what the law requires.''

LET us test the action of the respondents on the anvil of aforesaid test. Appellant was in regular checkup and the ultra -sound and other tests were conducted by the respondents doctors. On the advice of doctors, appellant was admitted in the hospital for conducting various tests and regular checkup on 16.6.1999 and was discharged on 18.6.1999. She was again admitted on 11.8.1999 and after conducting ultra -sound, she was advised to be admitted for normal delivery, the date which was given on 30.8.1999, though on 11.8.1999 it was said that effect of Rubella and IUGR will be explained. Appellant never got any treatment at ESI hospital. She was under regular treatment of the respondent -hospital. Torch Test was conducted on 18.1.1999 whereas effects of Rubella were explained on 11.8.1999 i.e., after seven months of the said test. So much so four ultra -sound test performed on 7.1.1999, 19.1.1999, 19.5.1999 and 11.8.1999 showed that child was normal. Thus the possibility of incorporating the ''Rubella'' rogue at later stage to save its skin cannot be ruled out as child was born with injuries on the right ear, upper lip that was cut, injuries on the upper portion of the mouth over the tongue, injuries on the right ear and chopped right hand also cannot be ruled out as in the first ultrasound there was no indication as to the fetal retardation and malformation. Again in the second ultra -sound only heart beat was effected. It was in the third ultra -sound that growth retardation was effected.

THUS from any aspect we may hold up the matter the respondent hospital cannot escape from the charge of medical negligence amounting to deficiency in service. This is a spine shivering case that requires, to be visited with commensurate compensation though no amount will relieve the child and his parents from the life -long burdensome life. In our view, compensation/damages of Rs. 5,00,000 (rupees five lakhs) and cost of litigation of Rs. 5,000 would meet the ends of justice.

APPEAL is allowed to the aforesaid extent. Payment shall be made within one month.

A copy of this order as per the statutory requirements, be forwarded to the parties free of charge and thereafter the file be consigned to Record Room. Copy be sent to all the Presidents of District Forum for circulation against members. Appeal allowed.