KUMARI SHIVANI SINGH vs ASHWINI GOKHALE

ALLEGING medical negligence in administering liquid Gramoneg (Nalidixic Acid) and thereby causing loss of vision of both the eyes of the infant child Shivani, the appellant Shivani filed a complaint claiming compensation of Rs. 11,45,551 in all. The complaint was dismissed. Feeling aggrieved by the order of the Maharashtra State Commission, the present appeal has been filed.

THE case of the complainant/appellant is that her mother Mrs. Manisha Singh was under treatment of the Gynecologist Dr. Mrs. Ashwani Gokhale. On 17.5.1994 at 5.15, she gave birth to the appellant. It was normal delivery. THE newly born child Kr. Shivani Singh had some loose motion due to abdominal infection on 20.5.1994. THE complication arose due to frequency of 7 to 8 loose motions passed by Shivani Singh. On the same day since Shivani''s stool had a watery greenish tinge and a foul smell, Dr. Mrs. Ashwani Gokhale suspected that Shivani''s loose motions might not only be due to transitional diarrhoea but the same might be due to bacillary infection. She tried to consult Dr. Nisha Munshi on telephone around 6.00 p.m. but she was not available. Hence, had given Shivani teaspoonful of Walamycine liquid at 7.00 p.m. At the same time, Dr. Ashwani Gokhale had given a prescription of liquid Gramoneg to her. As was advised, they bought liquid Gramoneg (chemically known as Nalidixic Acid). Dr. Ashwani Gokhale administered half teaspoonful Gramoneg to the child, leading to the loss of vision. On 21.5.1994 the appellant was shifted to and admitted in Gokhale Hospital where she was cured but later on it was alleged that the appellant suffered due to the alleged dose of Gramoneg (Nalidixic Acid). It resulted into R.O.P. Grade-V. Dr. Kolte certified prima facie Persistent Hyperplasis Primary Vitreous (P.H.P.V.) was ruled out and it is claimed that the appellant became visually disabled due to negligence in administering the said dose of Gramoneg. THE complainant accordingly filed a complaint claiming compensation including total expenditure of treatment of loss of the salary by both the parents, requiring expenditure of maintenance and expenditure required for equipments for learning brail for the complainant which is totalled to Rs.11,45,551. Dr. (Mrs.) Ashwani Gokhale denied all the allegations stating there was no evidence to point out deficiency in rendering medical service. The patient was never administered liquid Gramoneg. She did prescribe medicine but made it clear that the medicine was to be given only after consultation with Dr. Nisha Munshi. In order to control diarrhoea, she had administered Walamycin which was already available in the hospital. The parents of the complainant though brought liquid Gramoneg. After reading the literature of Gramoneg that the medicine was contraindicative to be given to a baby below three months and the said medicine could not be given. She then consulted Dr. Nisha Munshi who advised Walamycin. The blindness of the patient was due to some reason like persistence congenital disorder like "Persistence and Hyper Plasia of Embryonic Introculer Vascalature" (P.H.P.V.). This reason was often discovered only after few weeks for the child could not fix its vision.

We have heard the learned Counsel for the parties at length and gone through the record. The main point which need our consideration is whether the medicine Gramoneg was administered by Dr. Ashwani Gokhale. Here there is affidavit evidence of the parents of the complainant. On the other hand there is affidavit of Dr. (Mrs.) Ashwani Gokhale as well as Dr. Nisha Munshi. Dr. Nisha Munshi corroborated Dr. Ashwani Gokhale about the telephonic contact made by Dr. Gokhale on 20.5.1994 and about informing her that she had administered teaspoonful of Walamycin at 7.00 p.m. to the patient. She also corroborated Dr. Gokhale that Dr. Gokhale had given a prescription of liquid Gramoneg to Shivani''s parents as a precautionary measure and had also cautioned that the same could be administered only after consultation with her (Dr. Nisha Munshi) on her advice and not before. Dr. Gokhale told that Shivani''s parents had already purchased liquid Gramoneg. Dr. Nisha Munshi further averred that she had decided that the earlier medicine Walamycin be continued as Dr. Gokhale had already read the caution stated on the carton of liquid Gramoneg and had informed her of the same that liquid Gramoneg was contraindicative for children below three months. She examined Shivani on 21.5.1994 at about 10.30 a.m. and noticed that Shivani could have been affected by infection resulting in metabolic acidocis and increased likelihood of intracranial pressure in Shivani. Insofar as the question of retinal disorder was concerned, she stated that certain retinal disorders could often be detected after 6-8 weeks because of the absence of expected milestones i.e., absence of fixation of gaze or white populary reflex at 6 weeks would include retinal pathology. She further asserted that on 17.5.1994 she could not have detected any retinal congenital disorder as the same could have been detected only after 6-8 weeks after birth.

AS per medical literature on eyes 28.11.3 Retinopathy of Prematurity (Retrolental Fibroplasia), the Medical literature suggests that no treatment has proved effective in progressive ROP. Pholocoagulation, diathermy, and crotherapy have been tried in rapidly progressive disease, but reports of favourable results by these methods of treatment must be qualified because of the high incidence of spontaneous regression. Preliminary reports to date suggest that cryotherapy of the avascular peripheral retina may prove to be the most useful of these modalities. Retinal detachment may necessitate vitrectomy and scleral buckling operation. Vitamin E may be effective in reducing the severity of acute ROP but because of serious side effects (scpsis, necrotizing enterocolitis, retinal haemorrhage, interacerebral haemorrhage) associated with high blood levels of this drug, using supplemental vitamin E above physiologic blood levels should still be considered experimental. In regard to the original congenital disorders Clinical Ophthalmology of Jack J. Kanski, MD, MS, FRCS, FRCOphth, Consultant Ophthalmic Surgeon, Prince Charles Eye Unit, King Edward VII Hospital, Windsor also suggests the stage of screening in following words : "The eye of all infants both at less than 36 weeks or weighing less than 1500 g, who have received supplemental oxygen, should be screened for ROP. Babies who have other systemic complications, such as intraventricular haemorrhage, are at increased risk of developing, however of very limited value because the pupils are difficult to dilate and visualisation of the funds is impaired by vitreous haze caused by the tunica vasculosalentis. The most useful time to screen an infant is between the post-conceptual ages of 32 and 36 weeks. This is because ROP rarely appears for the first time after 36 weeks, and retinal detachment seldom develops before that time. The pupils in a pre-term infant should be dilated with 0.5 cyclopentolate with or without 2.5% Phenylephrine."

IT would be further apparent from the following observation in "Retinopathy of Prematurity" that there are not one but several causes including an infection like bacillary infection. The observation reads as under : "The appearance of ROP in full-term infants and in new-borns with brief or no exposure to supplemental oxygen has led to a clouded understanding of its pathogenesis. An increased risk occurs with increasing duration and high levels of oxygen has been demonstrated as safe in the treatment of prematurely born infants. Current nursery practices vary but in general capillary blood-gas levels of 45 to 60 mm. Hg are recommended. Other factors that may increase the risk of ROP include anemia infection, intracranial haemorrhage, acidosis, general anaesthesia, patent ductus arterious, translation, bronchopulmonary dysplasia, and multiple births."

(Emphasis supplied) Since there are several causes of ROP and there is no evidence to exclude other causes, it could not be said that the complainant lost her eyesight on account of the fact that liquid Gramoneg was administered. If a congenital retinal disorder was there, it could not have been detected by Dr. Nisha Munshi, at that early stage. Consequently no medical negligence could be attributed to the respondent. It may be further mentioned that Dr. Ajit Rajaram clarified that the parents gave the history of admission of Nalidixic Acid to the baby but it was not possible for him to positively diagnose, if Nalidixic Acid was administered to the baby and that was how he put the question mark in the discharge card. He asserted by saying in his affidavit that he did not find any relationship or proximity of baby''s condition during her stay in his hospital and subsequent detection of blindness of Shivani Singh; even the medical reports produced on record did not indicate that blindness could have been caused by Nalidixic Acid.

MANY Ophthalmologists have tried their best to rectify the defect for the complainant but failed. It is not that one doctor says so but a team of different doctors from different places expressed the same opinion that the condition of the child was P.H.P.V. and none has expressed any definite relationship of her blindness to one dose of Gramoneg (Nalidixic Acid) if ever given to her even once.

IN view of the above discussion, it is not possible to say that the liquid Gramoneg was administered and as a result thereof the child has suffered loss of vision to hold that respondent was negligent in rendering medical service. For the aforesaid reasons, we do not find any force in this appeal and it is dismissed accordingly, leaving the parties to bear their own cost. Appeal dismissed.