1. THIS complaint has been filed by V. Krishankumar against opposite parties, viz., The State of Tamil Nadu, through Secretary, Department of Health, opposite party No. 1; the Director, Government Hospital for Women and Children, opposite party No. 2; Dr. S. Gopaul, opposite party No. 3; and Dr. Duraiswamy, opposite party No. 4 for deficiency in service and medical negligence in treatment of his premature baby. Brief facts of the case are:
Complainant''s version
2. V . Krishankumar''s wife Laxmi was admitted in Government Hospital for Women and Children, Egmore, Chennai on 30.8.1996. She delivered a premature female baby in 29th week of pregnancy as against normal period of 38 to 40 weeks. The birth weight of the baby was 1250 gms. The infant was placed in an incubator in intensive care unit for a period of 25 days until discharged on 23.9.1996. Admittedly the baby was administered 90 -100% oxygen at the time of birth. She underwent blood exchange transfusion a week after birth and also had apneic spells from time -to -time during first 10 days of her life. The baby continued to be under the care of opposity party Nos. 1 and 4. The complainant stated that opposite party No. 4, Paediatrician, Dr. Duraiswamy, who was working in the Neo -natology unit of the hospital, who knew the child''s history was requested to come for checkup at their residence even after discharge once in 10 to 15 days. Accordingly during the months of October, 1996 and November, 1996 Dr. Duraiswamy visited about six times for general checkup of the child, Sai Sharanya.
3. THE baby and her mother visited the hospital for followup care on 13.3.1996 at nine weeks of chronological age (33 to 42 weeks post -conceptional age). Opposite party No. 4 gave some prescription during his home visits as she was under his care from four weeks to thirteen weeks of chronological age (33 weeks to 42 weeks of post -conceptional age). The only advice given was to keep the baby isolated and confined to the four walls of the sterile room so that she could be protected from infection. His advice was meticulously complied with. However, it was never brought to the complainant''s notice that a premature baby who has been administered supplemental oxygen, blood transfusion is prone to a higher risk of retinal detachment nor was he informed by opposite parties that an internal examination of eye by an ophthalmologist was required. On the contrary, he casually made a statement regarding the child''s eye sight during her visit in October, 1986 that while a full term baby would take six weeks to focus at faces and smile this premature baby would take 16 weeks to focus as she was 10 weeks premature. Complainant kept waiting for completion of 16 weeks of baby believing the paediatrician -opposite party No. 4. Opposite party No. 4 never recommended about the risk of Retinopathy of Prematurity (ROP). Complainant took the baby to Dr. S. Gopaul, Neo -Paediatrician, opposite party No. 3, for complete checkup at his private clinic at Purassaiwakkam, Chennai as advised by him when the baby was 14 -15 weeks of chronological age (44 weeks of post -conceptional age). Admittedly, when he examined the baby at his private clinic even at that point of time it did not occur to him to get her eyes checkup leave alone ROP.
Learned Counsel for the complainant brought to our notice certain rudimentary details of the disease Retinopathy of Prematurity (ROP) and the consequences it would lead to if not treated in time. Prematurity is one of the most common causes of blindness and caused by an initial constriction and then rapid growth of blood vessels in the Retina. When the blood vessels leak, they cause scarring. These scars can later shrink and pull on the retina sometimes detaching it. The stage of ROP describes its severity. The disease advances through stages 1, 2, 3, 4 and 5 (5 being terminal stage). Normally stage 3 can be treated by Laser or Cryotherapy treatment in order to eliminate the abnormal vessels. Even in stages 4 and 5 the central retina or macula remains intact thereby keeping intact the central vision. When the disease is allowed to progress to stage 5 there is a total detachment (terminal stage) and retina becomes funnel shaped.
4. LEARNED Counsel for the complainant referred to some medical literature, which is given here as under:
"Literature Evidence in Support of the Consumer Affidavit in Respect to Retinopathy of Prematurity
Risk Factors
Retinopathy of Prematurity is diagnosed by retinal examination with indirect ophthalmoscopy, this should be performed by a paediatric ophthalmologist when the infant is 4 to 6 weeks old. We screen all infants with a birth weight less than 1500 gm or gestational age less than 32 weeks. Infants who are born between 32 and 34 weeks gestational age are examined if they have been ill.
The Retina
Retinopathy of prematurely (ROP) only occurs in those infants (typically of very low birth weight) whose retinal vessels have not yet completed their centrifugal growth from the optic disc. Hyperoxia of several events that appear to disrupt this natural progression.
The prevalence of visually impaired infants appeared to have remained low although the proportion of infants in whom changes were detected had increased in the past decade.
A strong association between changes of Prevention of Retinopathy of prematurity and both periventricular haemorrhage and evidence of hypoxic ischaemic brain injury diagnosed with ultrasound in the neo -natal period. At follow -up, almost all the infants had neuro developmental impairments.
Birth weight and gestational age
Most ROP is seen in very low -birth weight infants, and the incidence is inversely related to birth weight and gestational age. About 70 -80% of infants with birth weight less than 1000 gms show acute changes, whereas above 1500 gms birth weight the frequency falls to less than 10%.
Oxygen administration
It is evident that careful control of oxygen administration will reduce the incidence of ROP, but it has proved difficult to define a safe level of oxygen. The American Academy of Paediatrics has recommended that arterial oxygen concentrations be kept in the region of 50 -80 mmHg during neo -natal care, and this view has gained general acceptance. Most neo -natal units have well defined protocols for monitoring oxygen use in pre -term infants, but despite this there is still a disappointingly high incidence of ROP."
5. IT is stated that complainant''s brother -in -law met with an accident in Mumbai while driving his scooter and complainant went to Mumbai along with his family in January 1997 when the baby was 4 months old. In Mumbai the complainant casually took the child to a paediatrician, Dr. Rajiv Khamdar, for her DPT shots as well as general checkup. In that casual visit itself Dr. Khamdar suspected development of ROP in the baby''s eyes. He noticed that she was unable to move her eyes to movement of people and focussing on objects, even when she was eight weeks old, and opined that development of vision does not get delayed for premature babies. He suspected Retinopathy of Prematurity when he saw white reflects in the eye and referred the child Sharanya to a retinal specialist, Dr. S. Natarajan of Aditya Jyoti Hospital, Mumbai. The ultrasound was done (report -Annexure -D) which confirmed baby''s eye condition was ROP stage 5.
6. THE complainant contended that Dr. Rajiv Khamdar suspected ROP on a casual naked eye examination for a mere five minutes checkup and knowing nothing about the baby''s history whereas opposite party Nos. 3 and 4 who have been treating her for the past 3 months, could not detect the problem and hence it is clear medical negligence and deficiency in service on the part of the opposite parties. The disease has progressed from stage 1 to stage 5 due to gross medical negligence and blunder of non -detection and consequently giving no treatment at an early stage. Even a surgery at that stage has only a chance of success of 15 to 20% and even then the child would keep a vision of as low as 10 to 15%. Had the disease been detected even in stage three, Laser/Cryotherapy treatment could have been given and the child would have got excellent vision. On further investigation complainant found that high level of unmonitored oxygen and blood transfusion were high risk factors for ROP and contributed to fast advancement of disease.
7. TRAUMATISE D and shocked complainant rushed to Puttaparthy for the blessings of Shri Satya Sai Baba. On 13.2.1997, Sharanya was anestheticaly examined by Dr. Deepak Khosla, Consultant, Department of Ophthalmology at Baba Super Speciality Hospital at Puttaparthy. Dr. Khosla also said that it was a difficult case, both prematurity and high level of oxygen had contributed to this condition of retina. He did not want to take up the case since the ROP has reached stage 5 (discharge summary -Annexure E).
8. AFTER coming back from Puttaparthy, Sharanya was examined by Dr. Tarun Sharma along with the retinal team of Shankar Netralaya who also gave the same diagnosis. Hoping against hope that some ophtalmologist in this country would be able to give the baby good vision by his expertise and good treatment, the complainant took her to Dr. Namperumal Swamy of Arvind Hospital, Madurai on 1.3.1997 but the doctor felt that the eye vision of Sharanya was not very favourable for surgery.
9. IN June 1997 complainant searched on internet and read about Dr. Michael Tresse who is a renowned expert in Retinopathy treatment in babies in United States. Complainant consulted Dr. Badrinath, Chief of Shankar Netralaya, who gave his reference for surgery in United States. Complainant took his one and only child to United States with a fervent hope that there must be some remedial action, however slight, that could help child. Enormous expenses were incurred towards the surgery in United States until 2003 (Ex. B1, B2, B3, B4).
10. THE complainant finally understood the subject and contributing and causative factors for premature retinopathy and the consequences it would lead to if not treated in time. After reading the literature the complainant realized that all infants who had undergone less than 13 weeks of gestation or weigh less than 1300 gms should be examined regardless of whether they have been administered oxygen or not. ROP is a visually devastative disease that often can be treated successfully if it is diagnosed in time. Learned Counsel for the complainant stated that 2nd, 3rd and 4th opposite parties have failed either to have Sharanya treated for the above said disorder or to advise them to get an ophthalmologist to check up her eyes. A routine eye checkup of premature babies is normal and mandatory practice, which is necessary to be followed by maternity and child -care hospitals. The complainant also submitted that opposite party No. 1 does not have proper neo -natal specialist with the requisite qualifications, although they claim that 350 pre -mature babies are born every year. Since opposite parties have failed to exercise the basic and necessary standard of care, expected from any medical practitioner, who did not give any advice or expressed any pre -warning. or doubt or written a check list for complainants to do a followup after discharge from the hospital regarding Sharanya''s general eye management is nothing but gross medical negligence and deficiency in service. Due to lack of basic care and attention by the opposite parties, their only child has been affected by this terrible ailment, which has caused irreparable and irretrievable damage, loss and pain to the parents of the child.
11. THE complainant stated that he belongs to a middle class family and has very limited sources of income by way of employment and that he is the sole earning member of the family. He had to mobilize funds at high rate of interest to get medical treatment for the child. He alleged negligence on the following grounds:
(i) not informing the complainant that an eye problem could occur in a premature baby as retinal problem is supposed to be common in prematurely born babies and also easily correctible if diagnosed on time.
(ii) not giving the complainant the faintest idea that premature babies who is given supple -mental oxygen and blood transfusion are prone to a higher risk of retinal detachment.
(iii) not subjecting the child Sai Sharanya to an initial ROP examination.
(iv) not informing the complainant at any point of time that an internal examination of eye by an ophthalmologist was required nor informing them of the nature and possibility of ROP.
(v) neither checking the eyes of the complainant''s child either at birth or during their visit to the opposite party -hospital for the baby''s periodical checkup nor asking the complainant to get her eyes examined by an ophthalmologist. The third opposite party only prescribed an ultrasound of brain as he felt it was appropriate to do it for a premature baby who had apneic spells.
12. IN view of the grounds taken above, he prayed for the following reliefs such as to -
(a) Direct the opposite parties to pay a sum of Rs. 20 lakh towards Air Fare, Medical expenses and cost of stay at U.S.A., cost of treatment and medicines along with interest @ 18% on the above said sum.
(b) Direct the opposite parties also to a minimum sum of Rs. 30 lakh towards further treatment of the child at this stage and also to pay expenses in excess thereof.
(c) Direct the opposite parties to pay a sum of Rs. 50 lakh towards damages/compen -sation for pain, loss of future prospects, mental agony and terrible impairment caused by the negligence of the opposite parties to the infant and complainant.
(d) The cost of these proceedings.
(e) Any other further amount.
13. LEARNED Counsel for opposity party Nos. 2, 3 and 4 made the following submissions:
Laxmi Krishankumar came up with pre -term labour with bleeding and prolapse cord with the presenting part at the outlet. An immediate assisted breach delivery was done as the baby was very small. There was imminent threat for life of the baby with the cord prolapse for immediate assisted breach delivery. The baby was born prematurely 26 -28 weeks of gestational age with birth weight of 1250 gms. The death rate among this group is about 80 -90% in developing countries like India. Maternal bleeding before 26 -28 weeks of pregnancy would deprive oxygenation to the brain and related neurological system. Saving the life of the baby was the priority and the parents were explained about the outcome of this situation such as neuro motor developmental delay and visually as well as hearing handicaps at all stages of management of the baby during 24 days of their stay in the unit. The complications and the risks and alarm signs involved were explained and appraised at the time of discharge.
14. IT is submitted that with reference to the examination of eyes, at birth or immediately after birth, screening is advised after the neo natal period around 5 -8 weeks when ROP changes might take place. Earlier to that, performing screening for the problem will not reveal or predict the emergence of ROP. The baby was discharged on 24th day and hence the necessity of ophthalmological examination during the stay did not arise. At the time of discharge of the baby, there was no visual impairment and the mother was advised to bring the baby to the postnatal clinic meant for high risk babies. This advice was not followed by the mother even during treatment of child during the casual visit of opposite party No. 4.
15. IT is further stated that in the pre -term babies with low birth weights even after 6 weeks looking into retina with general anesthesia may sometimes produce cardiac arrest or aggravate neurological damage as well as to retina (Annexure R1 (b)).
16. THEREFORE , it is only preferred after 6 to 8 weeks and thereafter every four weeks till for a period of one -and -a -half years for resolving ROP. It is failure on the part of the complainant who chose not to attend the follow -up at the neo -natal unit for premature babies for detailed examination and counselling.
17. IN fact even after diagnosis of ROP and Viterectomy was recommended as a remedy in February 1997 the complainant delayed further for five months without taking any corrective measures. Had they reported to opposite party No.1, opposite party No. 1 could have referred to the Ophthalmologist in the Regional Institute of Ophthalmology and Government''s Eye Hospital. It is pitiable that the child''s treatment was delayed in India and then the complainant rushed to United States after lapse of five months. The factors resulting in the delayed development and ROP are:
1. Premature delivery before 26 -28 weeks.
2. Maternal Bleeding prior to delivery.
3. Cord prolapse with compression before the delivery.
4. Breech presentation in premature infant.
5. Severe birth Asphysia (lack of oxygen).
6. Respiratory arrest -Apnoea during the course of management.
7. Jaundice, which needed exchange blood transfusion.
18. IT is stated that ROP is not preventable as it may be due to prematurity, severe lack of or low oxygen during labour at birth, apnoea, acidosis, hyperbilirubinaemia and hypoxia are all the possible causative factors.
19. THE evidence of Dr. S. Natarajan, Dr. V. Ganesh of Chennai vaguely mentioned that ROP screening is done at the time of birth and after birth without giving any specific period for ophthalmic examination to sick pre -term baby. It is an accepted practice to undergo screening for ROP after stabilization and specific period around 5 to 7 weeks of post -natal life nationally and internationally. Even at that stage also the risk of such examination with anesthesia also brings complications (Annexure R -2). Dr. Pawan Kumar Pathak of Anand Eye Hospital, Madurai has stated that the child does not seem to be seeing is non -specific statement and no ocular examination was carried out by him at any stage and hence his statement is not tenable. Dr. Tarun Sharma of Shankar Netralaya has opined that the premature and low birth weight babies are vulnerable to such ROPs and the eyes can only be examined after completion of 5 to 8 weeks. The voucher of Rs. 5,000 given by Dr. Shyamala has nothing to do with opposite parties. This receipt has been given by her in a personal capacity and that she has nothing to do with opposite party No. 1. She is not employed in the hospital but she is only a research associate of Indian Council of Medical Research. Dr. Shyamala herself filed an affidavit (Annexure R -3) dated 3.9.1993 in this Commission disowning the contentions of the complainant. Learned Counsel contended that they were not given single chance of proper examination of the child in the post -natal follow -up clinic meant for premature babies. Opposite parties cannot be held liable for suffering of the child as alleged by the complainant. Complainant also produced a fabricated and forged document in evidence (Annexure R -2(B)) to show that he has brought the child to opposite party No. 1 for checkup whereas he never brought the child to the hospital. Learned Counsel prayed for dismissing the complaint as frivolous and vexatious with exemplary costs.
20. LEARNED Counsel for opposite party No. 1 submitted that the complainant paid an amount of Rs. 7873.50 towards Government''s hospital stoppage charges and drugs and nothing else was paid for the successful delivery and management of the baby. Regarding the amount of Rs. 5,000 which has been allegedly paid to Dr. Shyamala and receipt given by her in this regard, the affidavit filed by Dr. Shyamala itself says that this amount has been given in her personal capacity as their family physician based on personal relationship between the complainant and Dr. Shyamala. The bogus receipt from Dr. Shyamala cannot be relied upon based on her affidavit and the allegation that the patient attended as out patient on 30.10.1996 is false because it is not an out -patient day meant for as followup day for premature babies. The complainant produced a falsely fabricated continuation out patient sheet.
21. IT is further contended that the complainant is aware that Dr. Shyamala has nothing to do with the Institute of Obstretics and Gynaecology and Government Hospital for Women and Children, Chennai and that she is only a research associate of Indian Council of Medical Research. She is not employed in the hospital where the opposite parties 2, 3, and 4 are working.
22. BY filing bogus receipts and misinterpretation of the receipts issued by the Institute of Obstetrics and Gynaecology and Government Hospital for Women and Children, Chennai it is submitted that even though the complainant has not attended with his baby any time after delivery and he has fabricated and produced a bogus out patient ticket as if he has come to the hospital on 30.10.1996.
23. COMPLAINAN T has gone with the baby to Mumbai, to Puttaparthy Satya Sai Hospital, to Arvind Hospital, Madurai, Shankar Netralaya, Chennai and United States for the treatment without the knowledge of the opposite parties for his own whims and fancies and Government of Tamilnadu will not be responsible for taking private treatment. When all infrastructure, medical facilities are available free of cost there is no reason for the complainant to go to all these places when he could have got complete treatment from opposite parties.
As regards affidavit of Dr. S. Natarajan, Mumbai it is argued that the said affidavit reveals that he examined the baby only on 3.2.1997 at the age of five months of the baby. There is no evidence of all the treatments that has been given to the child at various hospitals and what type of ailments the baby suffered and the type of treatments that was given to the baby is not known as nothing has been disclosed by the complainants. "The opinion of Dr. S. Natarajan is based on conjectures and does not rule out the possibility of an irreversible congenital retinopathy due to prematurity".
24. AS regard the report of Dr. B. Ganesh, Chennai which also accepts that premature babies are also vulnerable to ROP. At the time of delivery on 30.6.1996 this defect could not have surfaced/ manifested as per the medical literature and Nelson''s Textbook of Paediatrics and Other recent Advancements (R -12) wherein it is noted that ROP will manifest only at 32 -40 weeks of post -conceptional age. In view of this theory, opposite party could not have found any defect in the vision of the baby at the time of discharge from the Government Hospital. The opposite parties never had any chance to examine the baby in her post -natal follow -up clinic meant for premature and high risk babies after her discharge. As for the medical report of Dr. Pawan Kumar Pathak, Arvind Hospital, Madurai dated 26.12.2003, it is argued that Dr. Pathak did not verify the condition of the baby by any examination by himself, which is not supported by any medical literature or evidence. As per the report of Dr. Tarun Sharma of Shankar Netralaya, Chennai, he does not find any fault with the treatment given by opposite parties. It only reflects condition of the child at the time of bare examination of the child. From all these reports that have been produced by the complainant nowhere it has been held that opposite parties were negligent at the time of delivery and management in the neo -natal period. From the records produced by opposite parties it is evident that at the time of delivery and management no deformities were manifested and the complainant was given proper advice which was not followed.
25. WITH respect to the evidence of the doctors above the learned Counsel further raises the following issues:
(a) Can the existence of Retinopathy of Prematurity be detected immediately on the delivery of the child?
(b) After how many weeks does it become detectable?
(c) Does Retinopathy of Prematurity always develop by stages or is it possible for Retinopathy of Prematurity to occur at one stage? Please substantiate answer with authority.
(d) Can there be genetic reasons for Retinopathy of Prematurity? Did the above said doctors examine the parents of the baby (Mr. V. Krishnakumar and Mrs. Lakshmi Krishnakumar) from this angle when they came to for consultation?
26. IT is further urged that the discharge summary referred to also contemplates the very nature of the baby and that the parents were never informed about the alarm signs. The expression alarm signs denote many more things, it denotes not only prematurity of the child but also the various complications like respiratory distress, apnoea spells, hypoxia, brain damage, mental retardation, visual, auditory and physical disabilities. Having all these complications that may develop in future, the answering opposite parties very pertinently advised the parents to attend post -natal follow -up O.P. on Tuesdays. This important advice never heeded by the parents and they have taken their own decisions, when, the complications said to have developed. They have taken the child to all places except to the post -natal O.P. on Tuesdays as advised.
27. WITH reference to the report of AIIMS, opposite parties also concurred that a premature baby is not born with ROP although it is one of the complications for the prematurity concurring with the guidelines to examine and screen the baby with birth weight less than 1500 gms and 32 weeks gestational age, starting at 31 weeks post -conceptional age (PAC) or 4 weeks after birth whichever is later. It was also concurred that for the last ten years and even before that the guidelines in general were the same and the premature babies were examined at 31 -33 weeks post -conceptional age or 2 -6 weeks. But the complainant has not approached the government hospital where the baby delivered for further necessary checkup in the above said age of the child.
28. THE baby''s parents were asked to attend the high risk follow -up post -natal out -patient clinic where premature new born babies followed up periodically until 2 years of age. On a given follow up day, 40 to 50 premature high risk babies attend (weekly clinic). The complainant has never attended the followup post -natal outpatient where the infrastructure for development assessment and early detection of disabilities is available.
29. IN the present case the complainant never gave chance to check up the baby at the crucial time.
30. OPPOSITE party referred to the article by Ropard extract of which being material is reproduced below:
"The eye starts to develop at about 16 weeks of pregnancy, when the blood vessels of the retina begin to form at the optic nerve in the back of the eye. The blood vessels grow gradually toward the edges of the developing retina, supplying oxygen and nutrients. During the last 12 weeks of pregnancy, the eye develops rapidly. When a baby is born full -term, the retinal blood vessel growth is mostly complete (The retina usually finishes growing a few weeks to a month after birth). But if a baby is born prematurely, before these blood vessels have reached the edges of the retina, normal vessel growth may stop. The edges of the retina and periphery may not get enough oxygen and nutrients."
31. LEARNED Counsel for the opposite party submitted that complainant is not a consumer and that the service rendered by opposite party is a free service. There is no deficiency in service or medical negligence that could be attributed to opposite party and it is the complainant alone who is negligent and deficient in his duty towards his child in not heeding to the advice of opposite parties and the complaint should be dismissed.
32. OPPOSITE party No. 4 in his affidavit stated that complainant was informed and explained of the various complications, that may arise in premature high risk baby since no Retinopathy of Prematurity was manifested at the time of discharge during the 3rd week of the child''s life. The question of giving instruction regarding high risk of retinal detachment did not arise. The un -manifested disease cannot be cured nor can a doctor give the treatment on presumptions and assumptions. It is submitted that it is pertinent to point out that when the child was brought to the third opposite party the baby was having good vision following light and light reflex was present when the 4th opposite party paid an emergency visit af the instance of the parents to allay the anxiety even then there was no manifestation of Retinopathy of Prematurity and he advised the parents to bring the child to post -natal premature high risk follow -up clinic for further checkup as advised earlier at the time of discharge.
33. DR . Duraiswamy, opposite party No. 4, further stated that the words alarm sign noted in the Discharge Summary means the risk of hypoxia (deficiency in oxygen) visual, auditory and physical problems. He further submitted that no fee was collected by him from the complainant and Rs. 5,000 was paid to Dr. Shyamala and the alleged payment of Rs. 5,000 paid by them to Dr. Shyamala is based on the personal relationship of the complainant and Dr. Shyamala and opposite parties are not concerned or involved in the same.
34. PURSUANT to our order seeking expert opinion, a medical board was constituted by AIIMS.
AIIMS Report
35. THE following report has been sent by letter, dated 21.8.2007, by AIIMS. AIIMS constituted a medical board, which consisted of five members, out of them, four are ophthalmological specialists. The Board has given their opinion in the following manner:
"A premature infant is not born with Retinopathy of Prematurity (ROP), the retina though immature is normal for this age. The ROP usually starts developing 2 -4 weeks after birth when it is mandatory to do the first screening of the child. The current guidelines are to examine and screen the babies with birth weight<1500g and <32 weeks gestational age, starting at 31 weeks post -conceptional age (PAC) or 4 weeks after birth whichever is later. Around a decade ago, the guidelines in general were the same and the premature babies were first examined at 31 -33 weeks post -conceptional age or 2 -6 weeks after birth.
There is a general agreement on the above guidelines on a national and international level. The attached annexure explains some authoritative resources and guidelines published in national and international literature especially over the last decade.
However, in spite of on -going interest world over in screening and management of ROP and advancing knowledge, it may not be possible to exactly predict which premature baby will develop ROP and to what extent and why."
Annexure Review of literature of ROP screening guidelines Year Source First Screening Who to Screen 2006 American 31 wks PCA or <1500 gms Academy of 4 wks after birth birth weight or Paediatrics whichever later < 32 wks GA or et al. higher 2003 Jalali S et al. 31 wks PCA or <1500 g birth Indian J 3 -4 wks after weight or < 32 Ophthal - birth -whichever wks GA or mology earlier higher 2003 Azad et al 32 wks PCA or < 1500g birth JIMA 4 -5 wks after weight or <32 birth - wks GA or whichever higher earlier 2002 Aggarwal R 32 wks PCA or <1500 gm birth et al Indian J 4 -6 wks after weight of <33 Paediatrics birth whichever wks GA earlier 1997 American 31 -33 wks PCA <1500 gm birth Academy of or 4 -6 wks after weight or < 28 Paediatrics et birth wks GA or al. hiqher 1996 Maheshwari R 32 wks PCA or <1500 gm birth et al. 2 wks after birth weight or < 35 National Med. whichever is wks GA or J. India earlier. O2>24 hrs. 1988 Cryotherapy 4 -6 wks after <1250 gms ROP Group birth birth weight
The complainant also filed medical literature from journal of the Indian Medical Association extracts of which being material are reproduced below:
"Retinopathy of Prematurity - Screening and Management Raj by Vardhan Azad, Parijat Chandra
Retinopathy of Prematurity (ROP) is a relentless disease of the retina in premature children that in advanced cases leads to blindness. A good screening programme ensures early detection and timely intervention. Surgical results in advanced stage of ROP are very poor. Creating awareness, training of specialists and development of viable ROP centres is an urgent need. New research insights have shown promise to prevent, detect and treat ROP.
Retinopathy of Prematurity (ROP) was first reported in 1942 by Terry as retrolental fibroplasias. It is a vasoproliferative disorder of the retina that occurs in premature children and may progress to retinal detachment and blindness. With better neo -natal care services, younger babies are surviving and the incidence of ROP has increased. Good screening programmes ensure early detection and timely intervention that prevents blindness. It is essential that nurseries develop their ROP screening protocols and coordinate with ophthalmologists to develop effective screening programmes. Cooperation and counselling of the parents is also of great importance, emphasizing the nature of the disease and the need for followup.
Programme planning and screening strategy in retinopathy of prematurity. Jalali S, Anand R, Kumar H, Dogra MR, Azar R, Gopal L.
Retinopathy of Prematurity (ROP) is one of the major emerging causes of childhood blindness. A well organized screening strategy and timely intervention can to a large extent prevent blindness due to ROP. This communication proposes a screening strategy and management plan to develop a model for the care of babies with ROP.
Retinopathy of prematurity: incidence and risk factors by Rekha S. Battu RR.
Methods: Examination of the eye was done in the neo -natal unit or in the neo -natal followup clinic by an ophthalmologist by indirect ophthalmoscopy at 4 -6 weeks post -natal age.
RESULTS: The incidence of ROP was 46%. Of the 100 babies screened, 21 had stage I, 14 had stage II, 8 had stage III and 3 had stage IV and V. The incidence of ROP was 73.3% among less than 1000 gm babies and 47.3% among <1500 gm babies. The incidence of ROP among 28 -29 weeks, 30 -31 weeks and 32 -33 weeks babies was 83%, 60% and 50% respectively. The maximum stage of ROP developed between 37 -42 weeks post -conceptional age in 69% subjects. On univariate analysis, gestation < or=32 weeks, anemia, Blood transfusions, apnoea and exposure to oxygen significantly increased the risk of developing ROP. On multivariate logistic regression analysis, anemia and duration of oxygen therapy were the significant independent predictors of development of ROP. Nine of the 46 babies underwent cryotherapy for threshold ROP.
CONCLUSION: The incidence of ROP among high risk babies is significant and duration of oxygen therapy and anemia are independent factors predicting the development of ROP. All high risk babies should be screened for ROP. cryotherapy is a relatively simple procedure which can be done in the neonatal unit.
Key clinical risk junctures in ROP disease by Michael T. Trese, MD
Communicate with the family
The fifth juncture is to document that the child must be examined following discharge from the hospital. The NICU should provide a document to be signed by the parents containing the time and place for a followup exam and advising them of the risk of blindness from ROP. The original should be kept in the patient''s chart and a copy provided to the parents. The families of premature infants need great care to guide them through this process. Caring and concern from the ophthalmologist may help avoid a lawsuit even in the face of a bad result."
Department of Neonatal Medicine Protocol Book, Royal Prince Alfred Hospital
Retinopathy of Prematurity
Diagnosis
The aims of screening for ROP are to identify ROP which has the potential to reach stage 3; and sever (stage 3) ROP which may require treatment.
Screening for ROP
should be carried out on all infants born at less than 32 weeks (or with a birthweight of less than 1500 gms.);
commence in all infants at 4 -6 weeks post -natal age (and those born at less than 28 weeks should be examined by 32 weeks post -menstrual age); and
be repeated at least every two weeks until vascularisation has progressed into the outer retina (zone 3).
For infants due for transfer or discharge home, it is important to ensure that the screening process is completed. Regardless of ROP, all pre -term infants need increased surveillance of visual functions during childhood.
Retinopathy of Prematurity by Rajiv Aggarwal, Ramesh Aggarwal, Ashok Deorari, Vinod K Paul, Division of Neonatalogy, Deptt. of Paediatrics, AIIMS, New Delhi
With improving survival of very low birth infants in India, Retinopathy of Prematurity (ROP) is likely to emerge as a significant problem. The most important risk factor in the pathogenesis of ROP is prematurity. Other factors like frequent blood transfusions; sepsis, apnoea and problems with oxygenation have also been implicated in the causation of ROP. Essentially asymptomatic in the initial stages, a good screening programme is essential for the early detection and treatment of this condition. Guidelines regarding the procedure of dilatation, ophthalmic examination and treatment (if required) has been provided in the protocol. Close cooperation between the ophthalmologist and neo -natalogist is essential for a successful programme."
36. CLASSIFICA TION of ROP, protocol for screening and the therapy and procedure and prevention of ROP and the post operative care have been described as brought out by division of Neo -natology, Department of Paediatrics, AIIMS.
37. WE have carefully gone through all the documents and the medical record, which have been filed by both the parties. In our view, the opposite parties have taken a technical view of only one ground that the complainant was required to attend the out patient ward for a followup on Tuesday whereas it is alleged that the complainant brought the child on a Wednesday. The opposite parties also alleged that complainant has filed bogus receipts to show that he had brought the baby on 30.10.1996 and that he never came to the hospital. We are unable to agree with this submission the complainant would have definitely taken the baby on Tuesday had he been given some inkling of these risks. Doctors cannot say they do not bother to do post -checkup of premature baby just because she is brought in next day i.e. Wednesday, even if the doctor is not a neo - natal specialist.
38. ADMITTEDLY the baby was born in the 29th week of pregnancy with a birth weight of 1250 gms as against the normal period of 38 to 40 weeks. It is also not disputed that the baby was administered oxygen at the time of birth and also underwent blood exchange transfusion a week after birth. The child also had apnoea spells from time -to -time during his first ten days of life. She was under the care of opposite parties for 25 days after birth. Opposite party No. 3 did a checkup at his private clinic when the baby was 14 to 15 weeks. Opposite party No. 3 admitted in his affidavit that he had examined the baby at his private clinic but at that time also it did not occur to him that the child could be having visual problem and hence he had never referred and give any direction regarding ROP.
39. THE medical literature clearly shows that the disease, if not diagnosed and treated at the initial stages, would lead to ROP. It is a known fact that prematurity is one of the most common causes of blindness. The complainant had stated that opposite party No. 4, Dr. Duraiswamy, visited the complainant''s house six times. Dr. Duraiswamy in his affidavit admitted that he made only one visit. There are prescriptions issued by Dr. Duraiswamy that complainant clearly alleged that the baby was under his care from 4 weeks to 13 weeks of chronological age. The complainant submitted that the only advice that was given to him by opposite party No. 4 was to keep the baby isolated and confined to the four walls of the sterile room so that he could be protected from infection but never informed him about the risk of ROP and advised to consult ophthalmologist at any time.
40. IT is just a coincidence that the complainant had to go to Mumbai for emergency personal matter where he had taken his daughter to a paediatrician, Dr. Rajiv Khamdar, on a casual visit for giving DPT shots when she was 4 months. Dr. Khamdar suspected ROP immediately by naked eye and thereafter it was confirmed by further test and ultrasound report that it was diagnosed as ROP stage 5. If Dr. Rajiv Khamdar suspected ROP on a casual naked eye examination within five minutes not knowing anything about baby''s history, in our view, opposite parties who are also specialists, working in the hospital treating number of babies, how it has not occurred to them to advise the complainant that the baby requires to be seen by an ophthalmologist. Having knowledge of this, they have never instructed the parents nor Counsel or educate them about the possibility of occurrence of ROP in such a high risk baby.
41. IN our view, parents should have categorically been informed before discharge that the baby should be screened for ROP even prior to discharge. No screening of the eye was ever made or recommended during the period child was in the hospital or even during subsequent visit to hospital on 30.10.1996 or the home visit made by opposite party No. 3 or even opposite party No. 3 who examined her in his clinic when the child was 3 months old. The reliance made by the opposite parties regarding the discharge summary where it is mentioned that "Mother confident; Informed about alarm signs; (1) to continue breast feeding (2) To attend post -natal O.P. on Tuesday" . It is contended by the complainant that nothing specific has been mentioned in the discharge summary as to an advice regarding screening for ROP. It is also averred that a causal scrawling made in a corner in the discharge summary mentioning that mother is confident and alarm signs are explained does not absolve them from their duty of making clear reference as to the impediments that may arise if proper checkups regarding the inherent risks involved in this particular case have not been properly written. After 23 days of stay in the hospital, it is for the hospital to give clear indication as to what is required to be done by the complainant in the interest of the child in clear terms. Opposite parties cannot take benefit of these scrawlings, which could mean anything and yet mean nothing. It is a general warning and nothing more.
42. THE complainant also averred that the hospital does not have a proper neo -natal Department. Hospital is not equipped properly. The specialist in the Department of Neo -natology informed the complainant to take the child back to the hospital on a particular date on any Tuesday as mentioned in the Discharge Summary specially in a high risk case of a premature baby why the Discharge Summary does not properly mention that post -discharge care which is required to be taken by the complainant regarding the baby is not clear. It is not necessary that after the baby is born that the parents would go back to the same hospital. They can go anywhere for second opinion and further treatment depending on the convenience and other factors involved in the treatment of child. Had the opposite parties mentioned the screening of ROP in the Discharge Summary with clear instructions complainant would have done the needful because there is an alert in his mind that the child requires to be screened and is to be seen by an ophthalmologist. The present case is crystal clear that at no stage the complainant was warned or told about a possibility of occurrence of ROP. It is also not the case of the opposite parties anywhere in their affidavit that they have explained this particular problem that may occur to the complainant which, in our view, is deficiency in service.
43. WE rely on the report given by the AIIMS which also shows that the child should have been screened for ROP specially when its birth weight is less than 1500 gms, as seen in the Annexure (review of literature of ROP screen guidelines) where important medical journals and American Academy of Paediatrics have been referred to. In the present case the child was less than 1250 gms and was also born prematurely at the age of 29 weeks of pregnancy. Although AIIMS did not give a clear indication regarding the deficiency in service or negligence their report itself regarding screening guidelines shows that the baby should have been screened. The report further states that ROP shall start developing 2 to 4 weeks after birth when it is mot mandatory to do the first screening of the child.
44. IN the present case the baby was discharged on 24th day and if ROP starts developing 2 to 4 weeks after birth when it is mandatory to do the first screening of the child the opposite parties could have done the same before the child was discharged as 24 days is only 6 days short of 4 weeks and the clear indication of 2 to 4 weeks is the time prescribed by AIIMS. Although the current guidelines have been extended from 2 to 6 weeks after birth, in the present case there is no whisper of that advice even after six weeks. Opposite parties Nos. 3 and 4 have seen the baby after the discharge at home and at the clinic and yet no such advice for screening ROP has been given nor have they stated so in their affidavits. This clearly show that opposite parties never considered the advice of ROP screening at any stage.
45. IN our view, opposite parties have failed in their duty of care by not writing anything in the discharge summary what is the post discharge care that needed to be taken by the complainant and the post -screening tests are required to be done for the welfare and proper growth of the child. In our view, not giving any such indication in the Discharge Summary and relying on one of the explained alarm signs does not mean that they have executed and discharged their duty. The complainant has gone helter skelter to various doctors all over the country starting from Puttaparthy to Chennai to Mumbai and also to the United States. One and only child that they have they tried every possible avenue to bring her some ray of eyesight to the child but this ray of hope has been squashed at the very beginning such as the complainant was completely blind to the need of the hour i.e. to get his child screened for ROP. By not getting this information and not bringing it to the notice of the complainant opposite parties have failed in their duty and we hold it as deficiency in service.
46. COMPLAINAN T has filed the cost of the medicines and various other expenses that he has incurred for treatment of his child. Relying on AIIMS report which clearly indicates that it is not possible to exactly predict which premature baby will develop ROP and to what extent and why we are not able to decide whether at what stage ROP has evolved or developed in the present case. But the glaring fact that the child has reached to stage 5 by the time she was just 4 months old and this stage is the ultimate stage of retinal detachment when nothing else could be done.
47. WHEN the opposite parties -doctors clearly say that they examined her till the age of four months and alarming symptoms were not noticed, it is obvious that they have not checked carefully her vision whereas during those check ups the child must have undergone various stages of ROP from 1 to 4 during these four months before reaching stage 5.
48. THE record clearly shows that Dr. Rajiv Khamdar checked the child at 4 months for an ordinary checkup for DPT and immediately found that there is need for the child to undergo screening for ROP itself clearly establishes that the opposite parties completely missed the visual problem that has occurred in the child. Since one is not clear as to exactly when this problem has started although the child is prone to it, it is difficult for us to assess any loss of the continuity of the loss of vision for the child that opposite party could be made liable to. All the same we do find opposite parties were negligent and did not own up to perform their duty of care, caution by ignoring the glaring problem that the child was suffering from. The child started developing ROP in her eye and was under their care and now opposite parties cannot absolve themselves by arguing that nothing can be done once ROP sets in. To accelerate death or aggravate a medical problem in the patient or not properly informing the patient any inherent known risks of a problem/disease by giving up or banning or ignoring to give treatment for the same is gross negligence and it can be considered that doctor failed in his professional conduct. There was no intention on the part of the doctor to test the child for ROP when it is glaring on the face of the child, regarding her vision and allowing the child to become blind is inexcusable and it cannot be considered to be a bona fide mistake and we hold that they were careless and hence amounts to clear deficiency in service.
49. DOCTORS working in the Government hospital, during the relevant time, were not allowed to do private practice. In this case, they attended the patient at home obviously because the child was born premature and required personal attention and opted to visit the baby on their own accord. They cannot rely on one advice noted in the discharge summary to come to the hospital on Tuesdays for followup in neo -natal department and that does not absolve their responsibility because they themselves attended the child on private visits.
50. MEDICAL literature warrants that the opposite parties adopt basic mandatory screening guidelines. But, in the present case, where the baby was a high risk case; being pre -mature with low birth weight, who was subjected to blood exchange transfusion and was also administered 100% oxygen at the time of birth, the basic duty is cast upon the opposite parties to clearly indicate in the discharge summary the mandatory screening procedures for ROP and also any other related risks, which has not been done by them. Just a mere mention of alarming signs in the discharge summary does not clarify anything to the parents. In our considered view, we have no doubt in our mind that the parents have not been cautioned about ROP or else they would have definitely consulted various doctors in the beginning itself, seeing their conduct when they found out about it when the baby was 4 months old.
51. OPPOSITE parties failed to clearly warn the parents in the discharge summary or otherwise, the inherent risks, which in our view, clearly is deficiency in service.
52. IT is difficult to assess the compensation in terms of the mental agony the child and the parents are suffering and subjected to it for life -time. We find in all Rs. 5,00,000 should be paid to the complainant jointly and severally by the opposite parties O.P. No. 1 and O.P. No. 3 in addition to cost of Rs. 25,000 within two months from the date of order. Complaint allowed.
