1. This complaint is filed by three complainants namely Master Rishabh Sharma (1) Smt. Pooja Sharma (mother of complainant -1) and Master Aman Sharma (brother as complainant-3) against opposite party Dr. Rama Sharma (OP-1) and four other opposite parties.
2. Pooja Sharma, the complainant No.2 (for the convenience referred as "Patient"), during her pregnancy, was under antenatal care of OP1 from September 2005. Her expected date of delivery (EDD) was 13.06.2006. It was a case of Placenta Prevea, OP-1 assured, that she can handle such cases. The premature delivery took place on 02.04.2006; baby was delivered by Caesarean Section (LSCS). It was a premature baby about 32 week''s age. There was no Paediatrician at the time of delivery, and no neonatal unit was in the hospital. It was alleged that, without proper facilities, the OP1 carried out delivery at her nursing home despite, there was no neonatal care.
3. Thereafter, on. 02.04.2005 baby was shifted to Maharaja Agrasen Hospital (OP2). It was kept under observation of consultant Paediatricians, Dr. G.S. Kochar (OP 3), Dr. Naveen Jain (OP 4) and a Senior Consultant Ophthalmologist- Dr. S.N. Jha (OP 5). The baby was in OP-2 hospital till 29.04.2005, but no test for ROP (Retinopathy of prematurity) was conducted within 4 to 5 weeks of birth. The OP-1 never cautioned the patient about such risk of ROP before or after the delivery. The patient attended the OPD as follow up visits at OP-2 on 04.05.2005 and 13.07.2005, but OP 3 and 4 did not advise anything about ROP. In the last week of November 2005, the mother noticed child''s abnormal visual response , therefore on 23.11.2005 eye examination and ultrasound were conducted at Nayantara Eye Clinic,Delhi, Thereafter, on 3.12.2005, it was finally diagnosed as a case of total retinal detachment- ROP Stage 5 at Shroff''s Charity Eye Hospital, Delhi. Then, the child was referred to Dr.Azad at AIIMS.
4. The mother/Complainant 2 approached OP-1 for explanation, but she shifted blame on OPs 2 to 4. Thereafter, OP-5 was consulted, who tried to avoid to comment, but later on, he referred the child/patient to Shankar Nethralaya, Chennai. The referral note was devoid of previous hospitalisation/treatment details. Thus, OPs failed to explain, why the test, within four to five weeks, was not conducted when the patient was under their custody? The OP falsely mentioned in the discharge summary dated 13.06.2005 that, test for ROP was done on 26.04.2005. The OPs attitude was not cooperative, complete treatment record was not given to the complainants, hence complainants initiated proceedings under Delhi Medical Council (DMC) to produce the medical record. The DMC vide order dated 14.12.2007 warned the OPs regarding supply of medical records.
5. Therefore, the complainants alleged that, it was the failure and negligence of OP-3 to 5 to treat the premature baby. OPs did not take proper NICU care for timely detection of ROP at stage I, during hospitalisation period of 4 weeks. The OP-2 could have prevented the development of ROP to stage 5 i.e. permanent blindness to the child. Hence, filed this complaint under Section 12 of the Consumer Protection Act on 19-11-2007 and prayed for total compensation of Rs.1,30,25,000/-, under different heads.
Defense:
6. The OP1 resisted the complaint and denied all allegations of negligence. OP1 admitted
that, from 16.02.2005 the patient was under her antenatal care, also took treatment for bleeding
per vagina, at Sucheta Kriplani Hospital on 12.03.2005. The OP 1 denied that, the delivery was
conducted in haste. On 02.04.2005 the patient came with profuse bleeding, therefore to avoid
complications and to save her, life OP-1 performed LSCS, as per prescribed standard medical
norms. It was performed in the presence of senior Pediatrician, Dr. Kapil Gupta who took proper
care of the baby after delivery. The patient was shifted with proper reference letter and explaining
the attendants about condition of baby. Therefore, there was no negligence on the part of the OP
1.
7. The OPs 2 to 5 filed a written version and contended that the OP 2, Maharaja Agrasen Hospital is being run by a charitable trust. The complainant was admitted as a general patient in semi-private category on 02.04.2005. The complainant concealed the fact about free treatment of Rs.50000/- provided to the baby by OP2 from 04.04.2005 to 29.04.2005. The baby was extremely critical at the time of admission with little chance of survival having multiple problems; it was admitted in NICU (Neonatal ICU) in critical condition. It was cyanosed with features of respiratory failure. Baby was put on mechanical ventilator immediately after admission. It was diagnosed as a case of Hyaline Membrane Disease (HMD). Therefore, surfactant therapy and mechanical ventilation was started. During the hospital stay the child developed pneumothorax, therefore, tube thoracotomy was done by the paediatric surgeon. Blood component therapy was given. The baby was kept on ventilator for 10 days. As per standard protocol, nursing and ophthalmic care was properly given to rule out ROP. Eye examination was conducted by senior ophthalmologist and retina specialist, Dr. S.N. Jha (OP5) on 26.04.2005 and found no ROP at the age of four weeks. Hence, the mother was advised to attend for child''s follow up in special OPD on Wednesday and Saturday, wherein high risk babies are followed up for neuro developmental assessment, visual and hearing screening. The OP3 constantly advised the complainant to attend the specialty clinic. Arguments:
On behalf of complainants:
8. The learned counsel for complainant Mr.Anup Kaushal, submitted that, the principle of
"res ipsa loquitor" should be applied in this case, because the OPs failed to produce medical
record, same was observed by DMC also. Counsel took strong objection to the AIIMS report
dated 11-05-2012, because it was a biased one, it has simply adopted the written versions filed by
the OPs without going into the details of negligence about alleged no ROP examination done on
26.04.2005 and no follow up instructions were given by OP3 . It is further submitted that, AIIMS
has supported the virtual plea of contributory negligence taken by the OPs without any material
on record before it.
9. The Counsel for the Complainant relied upon the recent Judgment of the Hon''ble Supreme Court in the case of V. Krishnakumar vs. State of Tamilnadu & Ors., JT 2015 (6) SC 503 in which the facts are similar and the child suffered ROP. The Hon''ble Court observed negligence on the part of the Opposite Parties, who failed to screen and manage the ROP during the advancing stage. It has made observation on the medical records like:
9. It must, however, be noted that the discharge summary shows that the
above writing was in the nature of a scrawl in the corner of the discharge summary
and we are in agreement with the finding of the NCDRC that the said remarks are
only a hastily written general warning and nothing more. After a stay of 25 days
in the hospital, it was for the hospital to give a clear indication as to what was to
be done regarding all possible dangers which a baby in these circumstances faces.
It is obvious that it did not occur to the respondents to advise the appellant that the
baby is required to be seen by a paediatric ophthalmologist since there was a
possibility of occurrence of ROP to avert permanent blindness. This discharge
summary neither discloses a warning to the infants parents that the infant might
develop ROP against which certain precautions must be taken, nor any signs that
the Doctors were themselves cautious of the dangers of development of ROP".
He also relied upon the Judgment of this Commission in the matter of Akhilesh Jain vs. Nobel
Hearing and Speech Therapy Clinic & Anr. III (2014) CPJ 61 (NC).
ARGUMENTS ON BEHALF OF OP1, DR. RAMA SHARMA
10. The learned counsel Mr. A. K. Sharma, for OP-1 submitted that the complaint is based on
wrong and manipulated facts. The OP1 acted in accordance with the practice accepted as per the
norms. The patient conceived in September 2009 whereas she approached OP1 on 16.02.2005.
The patient was advised routine ultrasound (USG) which was done by Dr. Manish Gupta on
21.02.2005. The USG revealed risk factors to the child and the mother; therefore, it is false to
state that the OP1 assured normal delivery. On 11.03.2005, the patient came with bleeding PV,
she was treated conservatively and was referred to Sucheta Kriplani Hospital on 12.03.2005. The
counsel denied that the delivery was conducted in haste. In fact as per USG report, it was a case of
Palcenta Succenturiate (Asymmetric Placenta Previa), hence elective caesarean (LSCS) operation
was unavoidable. Unfortunately the complainant No.2 went into pre-term labour, as placenta got
separated, therefore, on 2.04.2005 at 5.35 PM, LSCS was performed after informed consent and
with standard care. One unit blood was also transfused. A senior pediatrician, Dr. Kapil Gupta,
was also present, who received the baby immediately after delivery. The baby was preterm (32
weeks) with signs of HMD, condition of baby was informed to relatives and thereafter was shifted
to Maharaja Agrasen Hospital (OP-2) under care of Dr.G.S.Kochar. Hence, there was no
negligence on the part of the OP1.
ARGUMENTS ON BEHALF OF OPs 2 TO 5
11. The learned counsel Mr. R. K. Gupta argued on behalf of OP-2 to 5. The OP3 and 4 are also
present in person. The counsel vehemently argued that, the OP2-hospital is run by a charitable
trust. On 2.4.2005, the child and mother were admitted in the hospital as general patient in
semi-private category, but they were shifted to general ward with effect from 04.04.2005 to
29.04.2005 at their request. OP1 has given Rs.50,000/- approximately worth free treatment to the
patient in ICU with ventilators. Therefore, the complainants concealed this free treatment from the
Commission. The baby was admitted in the neonatal ICU in critical condition. It was diagnosed as
a case of HMD, started conservative therapy and mechanical ventilation. The baby developed
pneumothorax for which tube thoracotomy was performed by the pediatric surgeon. As per
standard protocol, regular investigations and Arterial Blood Gas (ABG) analysis were performed.
Blood component therapy was given. The baby was kept on ventilator for 10 days. Regularly, the
parents were informed about the critical condition of the baby and possible neuro development,
visual and hearing sequel. As per protocol, ophthalmic examination was advised on 25.04.2005 to
rule out Retinopathy of Prematurity (ROP). Dr. S.N. Jha (OP5), the senior ophthalmologist and
retina specialist conducted examination for ROP on 26.04.2005 which showed no evidence of
ROP. Since, there was no ROP at four weeks after birth, complainant 2 was advised to attend
follow up and review in the special OPD on Wednesday or Saturday between 4 to 6 P.M. It was
clearly explained to the parents about all the problems which premature babies may develop ROP.
The patient was extremely critical at the time of admission with little chance of survival.
12. The counsel for the OPs placed reliance upon several medical textbooks and medical literature on Pediatrics and Neonatology. He further submitted that the child was given due care at every point of time. Hence, the hospital or doctor should not be condemned as negligent with just only a misadventure. The AIIMS medical board report is supportive of the case of OPs and it categorically stated that the OPs provided treatment as per standard medical protocol and there was no negligence. The counsel also referred various judgments of Hon''ble Supreme Court and this Commission as follows:-
(i) Dr. Laxman Balakrishnan Joshi Vs. Dr. Trimbak Bapu Godbole & Ors., AIR 1969 SC
128.
(ii) Jacob Mathews Vs. State of Punjab and Anr. , (2005) SCC (Crl.)1369
(iii) The Bolam''s case, (1957) 1 WLR 582
(iv) Kusum Sharma Vs. Batra Hospital & Medical Research Centre , AIR 2010
SC 1050
(v) Indian Medical Association Vs. V.P. Shantha & Ors. , (1995) 6 SCC 651
(vi) Sh. Ajay Gupta Vs. Dr. Pradeep Aggarwal & Ors. , 2007 (3) CPR 117 (NC)
(vii) Samira Kohli Vs. Prabha Manchanda (Dr.) , 1(2008) CPJ 56 SC.
Findings:
13. We have perused the medical record of Sharma Medical Centre of OP1. The Antenatal
Medical Record clearly revealed that, proper ANC care was taken by OP-1. The USG report and
Discharge -Summary sheet from Sharma Medical Centre showed that, it was the case of Placenta
Previa (Placenta-Succenturiate posterior Lobes). Patient/complainant 2 was operated under spinal
anaesthesia for an emergency LSCS on 2.4.2005. The baby was diagnosed as Preterm (32 weeks)
with signs of HMD, therefore, after due information to the relatives, the child was shifted to
Maharaja Agrasen Hospital (OP-2) under care of Dr. G. S. Kochar. Therefore, we are of
considered view that, OP-1 conducted delivery with due care and referred the child and mother to
higher centre for neonatal care. There is no negligence on the part of the OP1.
14. Further it is relevant to note that the Delhi Medical Counsel(DMC)''s order which has opined about lapses on the part of Dr. Rama Sharma(OP-1) in providing medical records in accordance with Regulation 1.3.2 of Indian Medical Council (Professional Conduct, Equity and Ethics) Regulation 2002, has not observed any negligence on the part of OP 1.
15. We have perused the entire medical record of OP-2 hospital, the prescriptions of different eye clinics where the patient visited. Accordingly, at the time of admission in OP-2 on 2.4.2005, the general condition of baby was poor, it was diagnosed as "32 weeks pre term AGA with HMD" . (Appropriate for Gestational Age) Therefore, baby was treated in NICU with ventilator support, injection Surfactant was given gradually. The child was discharged on 29.4.2005 from OP-2, thereafter; the baby visited the OPD on 4.5.2005 and on 13.07.2005, Dr.Kochhar OP-2 advised BERA scan. On 23.11.2005, the child was taken to Nayantara Eye Clinic, B. Scan of eyes was performed. Thereafter, on 3.12.2005 the child was taken to Dr.Shroff''s Charity Eye Hospital, USG (B scan) was performed. It revealed Total Retinal detachment (ROP stage 5). The prescription of OP-2 revealed that, on 7.12.2005, child was brought to OP-2 again, but it was referred to Shankara Netralaya for opinion of Dr. Lingem Gopal at Chennai. But, on 13.12.2005, the patient took OPD consultation at Dr. Rajendra Prasad Centre for Ophthalmic Sciences, New Delhi. The OPD card clearly revealed it was a case of ROP stage 5. in the month of December, 2005 .
16. Our observations on the two letters on the file:-
i) One the complainants wrote on 04-08-2007 to the Medical Superintendent of OP2.
The relevant part of the said letter is reproduced as below:
Under the above enclosure we have received photocopies of some Medical Record
(uncertified) along with a case summary dated 13-06-2007.
The said summary states that on 26-04-2007 ROP examination on our baby was
conducted in the Ophthalmological unit of your hospital and review examination after two
weeks was also advised.
We are rather intrigued by this observation as it does not find mention anywhere in the
Discharge Summary nor is there any follow up advise.
Since both of us do not recollect any such examination conducted in our presence or
review advise and the said medical record is also totally silent about it, kindly provide us
with the entire record of the Ophthalmological unit, name of the Paediatric
Ophthalmologist who had conducted the ROP examination and his written report dated
26-04-2006 .
ii) OP-2 replied the letter on 24-08-2007, the relevant paragraph is;
"As per standard neonatal protocol, ophthalmological check-up was requested on
25-04-2005 to rule out ROP.
The ophthalmological examination was done in the Nursery on 26-04-2005 morning by
Dr. S. N. Jha, Senior Consultant Ophthalmologist. The written report of the
Ophthalmological unit is stated on page no.102 of the case record."
On perusal of page No.102 of the case record reveals some illegible handwriting noting, it is
reproduced as below:
26/4 by Dr. SNJ
No ROP
Review, 2 weeks.
Sign.
17. Therefore, on careful reading of paras 15 and 16 (supra), we are not convinced whether the
ROP screening was done by OP-5 on 26.4.2006?. The progress sheet is devoid of details about
ROP examination viz. who performed it, the method, instruments used and drugs (midrates/
tropicamide)/anaesthesia used during ROP testing. The doctor has not mentioned any details of
dilatation of pupil and findings of Indirect Ophthalmoscope findings, the intra ocular or extra
retinal findings. Thus, it was a casual approach of OPs towards premature baby. The OP-5 has not
followed standard ROP screening protocol. Thus "No record means, it was Not done". Even the
nurses'' daily record on 25.4.2005 to 27.4.2005 does not show any ROP examination was done by
OP 5.
Expert Opinion
18. The Medical Board at AIIMS gave the expert opinion in compliance of the order of this
Commission dated 29-02-2012. It is reproduced as below:
Treatment of Mother:-
After examining the documents in the case file it was found that the medical treatment
provided by Sharma Medical Centre, New Delhi was in accordance with normal protocol
of treatment for Mrs. Pooja Sharma''s medical condition.
Treatment of Baby:-
A. Referral of the baby to better care facilities of Neonatal ICU at Maharaja Agrasen
Hospital, Punjabi Bagh, New Delhi from Sharma Medical Centre, B-112, Subhadra Colony,
New Delhi at treatment continued from 02.04.2005 to 29.04.2005 for hyaline membrane
disease, neo-natal jaundice, bilateral pneumothorax with fungal septicemia was also found to
be in accordance with normal protocol of treatment.
B. As per standard guidelines (National Neonatology Forum), newborn babies who are born
at 32 weeks gestation or lesser should have their eyes examined at 3 ? 4 weeks of age and
more frequent check-ups are to be done thereafter. Dr. S.N. Jha, examined the baby at 24 days
of age which was in accordance with established protocol.
C. If ROP screening does not reveal any ROP, then repeat examination should be performed
after two weeks. In case of finding of any ROP a closer follow up is required. Dr. S.N. Jha did
not find any ROP in his first examination of the baby on 26.04.2005 and advised a follow up
visit after two weeks which again was in accordance with established protocol. The baby was
discharged after 3 days (on 29.04.2005) of eye examination and was advised to report back
after two weeks period in Paediatrics OPD Clinic on Wednesdays or Saturdays from 4 PM to
6 PM.
D. As per records, the baby was brought after 5 days i.e. on 04.05.2005 for morning general
OPD (09.00 to 11.00).
E. Thereafter, the patient was brought again after more than two months i.e. on 13.07.2005
again to morning general OPD of this hospital.
F. There are no records to show that the baby was brought after two weeks of discharge to
the Pediatrics OPD Clinic on Wednesdays or Saturdays from 4 PM to 6 PM (the special clinic
for follow up of such babies where these examinations are done) as per advice given in the
discharge slip.
It seems the baby was not brought to the Pediatrics OPD Clinic on Wednesdays or Saturdays
from 4 PM to 6 PM after two weeks of discharge when subsequent progression of ROP could
have been assessed and treated on time.
We find that, this report did not comment about details of ROP screening and the follow up
findings on 4.5.2005.
Medical Literature on ROP:
19. In this regard, we have accessed number of medical literatures on ROP and text books of
Paediatrics, Neonatology to know about the guidelines for screening of ROP and its treatment.
20. About the screening programme in NICU, the article, ''Programme planning and screening strategy in retinopathy of prematurity" , Indian J Opthalmol 2003; 51:89-97, its relevant text is reproduced as below:
When should screening begin?
A premature infant is not born with ROP. The retina is immature, but this is perfectly
natural for their age. It is the post natal developments in the retinal vessels that could lead
to ROP. The sequence of events leading to ROP usually takes about 4-5 weeks except in a
small subset of premature infants who develop rush disease in 2-3 weeks. Therefore,
routine screenings should begin at no later than four weeks after the birth and possibly
even earlier for infants at higher risk (2-3 weeks) It is strongly recommend that one
session of retinal screening be carried out before day 30 of the life of any premature baby.
The examination should be done with the dilation of pupil by tropicamide .5% to 1% with
phenylapinephrine 2.5%.
Where the examination should be done?
When preparing the screening away from one''s own office, the ophthalmologist should
ensure from a checklist that all instruments/forms needed are packed. The place of
screening must be warm and clean enough for the baby. This is often the nursery/office of
the neonatologist but can also be the office of the ophthalmologist. The baby should be
well clothed and wrapped; and the baby should be preferably fed and burped an hour
before evaluation. Babies who are critically ill or in NICU are evaluated in the
NICU/incubator under the guidance of the neonatologist, monitored by a pulse oximeter.
21. The revised policy statement on "Screening examination of premature infants for
retinopathy of prematurity (ROP) of American Academy of Paediatrics (AAP) was published
in the February 2006 issue of Paediatrics.
http://pediatrics.aappublications.org/cgi/content/full/117/2/572 ). It is recommended that,
A retinal screening examination should be performed after pupillary dilation using
binocular indirect ophthalmoscopy on all infants with a birth weight of less than 3 lb, 5 oz
(1,500 g) or a gestational age of 32 weeks or less. Examination also should be performed on
selected infants with a birth weight of 3 lb, 5 oz to 4 lb, 6 oz (1,500 to 2,000 g) or a
gestational age of more than 32 weeks with an unstable clinical course.
Knowledgeable and experienced ophthalmologists should perform retinal examinations on
preterm infants and classify, diagram, and record findings using the standards from the
International Committee for the Classification of Retinopathy of Prematurity.
The initiation of acute-phase ROP screening should be based on the infant''s age because the
onset of serious ROP correlates more with postmenstrual age (i.e., gestational age at birth
plus chronologic age) rather than postnatal age. Thus, the youngest infants at birth take the
longest time to develop serious ROP.
The ophthalmologist should recommend follow-up examination based on retinal findings
categorized by the international classification. Physicians who are involved in
ophthalmologic care of preterm infants should be aware that the findings calling for
consideration of ablative treatment were recently revised using results from the Early
Treatment for Retinopathy of Prematurity Randomized Trial Study. Acute retinal screening
examination conclusions should be based on ophthalmoscopy findings and infant age.
Parent and staff communication about ROP is important, and documentation of these
conversations is recommended. Each new-born intensive care unit should define
responsibility for examination of at-risk infants. Each unit should have specific criteria
based on birth weight and gestational age, and the criteria should be established through
discussion and agreement between the neonatal and ophthalmology departments.
22. The recent article "Retinopathy of Prematurity: Past, present and future" World J
Clin Pediatr 2016;5(1):35-46 discussed about screening of ROP. The important text is
reproduced as hereunder;
Examinationtechnique:
The examination technique traditionally involves two steps namely the dilatation of pupil and
indirect ophthalmoscopy preferably with a 28D lens. It is preferred to perform pupillary dilatation
45 min prior to commencement of the screening. Dilating drops used are a mixture of
cyclopentolate (0.5%) and phenylephrine (2.5%) drops to be applied two to three times about
10-15 min apart. Alternatively, tropicamide (0.4%) may be used instead of cyclopentolate. Diluted
cyclopentolate may also be used to reduce probable systemic adverse effects. Use of atropine is to
be avoided. The neonatal nurse should be instructed to wife any excess drops from the eye lid to
prevent systemic absorption and complications like tachycardia and hyperthermia. If the pupil is
resistant to dilatation, it may indicate presence of persistent iris vessels (tunica vasculosa lentis)
and must be confirmed by the ophthalmologist before applying more drops. The United Kingdom
guidelines do not mandate use of eye speculum (e.g., Barraquer, Sauer, Alfonso specula) and
scleral depression (e.g., Flynn depressor) with topical anaesthesia. However, meticulous
examination, warrants its use.
Treatment modalities :
Cryotherapy treatment of avascular retina.
Indirectlaserphotocoagulation of the peripheral retina using indirect delivery system has
proved to be the gold standard, time tested and successful means of treatment since many
years. The biggest advantage is that it can be done under topical anesthesia.Pharmacologic
therapy is thus ushering a new era of ROP management.
Anti-vascularendothelialgrowthfactorsdrugs which block the effects of VEGF, and a single
intravitreal injection is less time consuming and less expensive as compared to lasers.
Exceptionally successful results with anti-VEGF drugs in adult retinal vascular diseases led
to its trial in paediatric retinopathy as a monotherapy as well as in combination with lasers.
23. AIIMS-NICU Protocols 2010 and NNF guidelines:
Retinopathy of prematurity (ROP) is emerging as one of the leading causes of preventable
childhood blindness in India. Screening for ROP should be performed in all preterm neonates who
are born < 34 weeks gestation and/or < 1750 grams birth weight; as well as in babies 34-36
weeks gestation or 1750-2000 grams birth weight if they have risk factors for ROP. The first
retinal examination should be performed not later than 4 weeks of age or 30 days of life in infants
born 28 weeks of gestational age. Infants born < 28 weeks or < 1200 grams birth weight should
be screened early, by 2-3 weeks of age, to enable early identification of AP-ROP. The retinal
findings should be classified and documented based on the International Classification of
Retinopathy of Prematurity guidelines (ICROP). Follow up examinations should be based on the
retinal findings and should continue until complete vascularization or regressing ROP is
documented or until treated based on the ETROP guidelines. Laser photocoagulation delivered by
the indirect ophthalmoscopic device is the mainstay of ROP treatment. The responsibility of
recognition of infants for screening lies with the paediatrician/neonatologist. Communication
with the parents regarding timely screening for ROP, seriousness of the issue, possible findings
and consequences is extremely imp. The Pre-term babies who have had problems after birth such
as lack of Oxygen, infections, blood transfusions breathing trouble, etc., are also vulnerable.
Follow the "Day-30" strategy. The retinal examination should be completed before "day-30" of
the life of a premature baby. It should preferably be done earlier (at 2-3 weeks of birth) in very
low weight babies (<1200 grams birth weight). ROP is treated with Laser rays or a freezing
treatment (Cryopexy). The treatment helps stop further growth of abnormal vessels thus
preventing vision loss. ROP can progress in 7-14 days and therefore, needs a close follow-up till
the retina matures. Therefore, ROP needs to be treated as soon as it reaches a critical stage called
Threshold ROP. There is 50% or greater risk of vision loss if left untreated after this. Time is
crucial.
After treatment if treated in time, the child is expected to have reasonably good vision. All
premature babies need regular eye examinations till they start going to school. ROP is easily
detected by periodic fundoscopy starting from 20-30 days of birth. Any person trained in neonatal
fundoscopy can screen for ROP. Main instrument used is the binocular indirect ophthalmoscope.
Conclusion:
24. Because ROP is sequential and timely treatment has been proven to reduce the risk of
vision loss, it is imperative that at-risk, infants receive carefully timed retinal examinations and
that all physicians who care for at-risk, preterm infants should be aware of the importance of
timing.It should be borne in mind that, screening for ROP needs to be initiated timely after birth
to prevent blindness. It is the responsibility of the caring pediatrician to initiate screening by
referring to an ophthalmologist and it is the responsibility of the ophthalmologist to do correct
screening and treatment. This has immense medico legal implications because if a child goes
blind due to missed or late screening, then the pediatrician and the ophthalmologist are at a very
high risk of litigation.
25. In the instant case, the main question swirls around, whether, the OP-5 performed ROP screening or not, at OP-2 hospital? ROP screening is a team work of paediatrician, ophthalmologist and NICU nurse. On the basis of discussion in foregoing paras, we find many lapses on the part of the OPs like no proper medical documentation of ROP screening procedural details. It should be borne in mind that, as per referral on 25.4.2006, the OP-5 should have performed retinal examination with binocular indirect ophthalmoscope on dilatation of pupil with scleral depression to ascertain avascular zone at periphery of retina. Nothing is forthcoming from page 102 of the medical record. Therefore, it appears to be a bare visual examination done by OP 5 in haste to cover up the case. Thus, we are of considered view that, on 26.4.2005 the OP3 to 5 have neither performed ROP screening nor advised follow up of ROP for the child. The patient visited hospital on 3.5.2006 for follow up, but nothing is in record about ROP testing. It is not a standard of practice or due care of the patient. Thus, a medical negligence.
26. It is pertinent to note that, in the instant case, the baby was premature, 32 weeks, the weight was 1500 gms. The team of doctors at OP-2 should have been alert about the chances of ROP in the premature baby/complainant No.1. It is very vital that judicious oxygen therapy and judicious use of blood transfusions Transfusion of packed RBCs is another risk factor of ROP. Adult RBCs are rich in 2,3 DPG and adult Hb binds less firmly to oxygen, thus releasing excess oxygen to the retinal tissue. Packed cell transfusions should be given, when haematocrit falls below, following ranges: ventilated babies 40%, babies with cardio-pulmonary disease but not on ventilators 35%, sick neonates but not having cardiopulmonary manifestations 30%, symptomatic anemia 25%. But, in the instant case blood component therapy was given. Therefore, we hold both the Paediatricians (OP 3 and 4,) along with OP-5 liable for the said negligence.
27. Expert''s silence:
The counsel for complainant vehemently resisted the AIIMS medical board report. On perusal of
said report, we also agree that, the opinion did not discuss the details about the ROP screening,
whether done by OP-5 or not. In the case Ramesh Chandra Aggarwal vs. Regence Hospital
Ltd. & Ors. (2009) 9 SCC 709, the Hon''ble Supreme Court held that;
" the real function of an expert is to put before the court all the material, together with
reasons which induce him to come to the conclusion, so that the court, although not an expert
may from its own judgment by its own observation of those materials".
Who is liable?
28. In Rogers v Whitaker, [1992] HCA 58; 175 CLR 479 where the issue was the extent of a
doctor''s obligation to inform a patient of the risks inherent in proposed treatment, the Court based
its decision squarely upon the duty of the doctor to observe the appropriate standard of care and
not upon any fiduciary relationship. The majority said:
"The law imposes on a medical practitioner a duty to exercise reasonable care and skill in the
provision of professional advice and treatment. That duty is a ''single comprehensive duty
covering all the ways in which a doctor is called upon to exercise his skill and judgment'' ; it
extends to the examination, diagnosis and treatment of the patient and the provision of
information in an appropriate case . It is of course necessary to give content to the duty in the
given case."
29. Hon''ble Apex court discussed the duty of doctor in the judgment Laxman Balkrishna
Joshi vs Trimbak Bapu Godbole And Anr. 1969 AIR 128. Court observed that;
" A person who holds himself out ready to give medical advice and treatment impliedly holds forth
that he is possessed of skill and knowledge for the Purpose. Such a
person when consulted by a patient, owes certain duties, namely, a duty of care in deciding
whether to undertake the case, a duty of care in deciding what treatment to give, and a duty of
care in the administration of that treatment. A breach of any of these duties gives a right of action
of negligence against him. The medical practitioner has a discretion in choosing the treatment
which he proposes to give to the patient and such discretion is wider in cases of emergency, but,
he must bring to his task a reasonable degree of skill and knowledge and must exercise a
reasonable degree of care according to the circumstances of each case."
It is thus clear that, the OP-3- to 5 in the instant case failed to exercise reasonable care and
skill.
Vicarious Liability:
30. Hon''ble Supreme Court and this Commission, in a number of judgments held that, hospital
will be vicariously liable on numerous grounds, on different occasions. Employers are also liable
under the common law principle represented in the Latin phrase, "qui facit per alium facit per
se", i.e. the one who acts through another, acts in his or her own interests. We place reliance
upon Savita Garg Vs. National Heart Institute , (2004) 8 SSC 56 , Balram Prasad v. Kunal
Saha , (2014) 1 SCC 384 and Smt. Rekha Gupta v. Bombay Hospital Trust & Anr. [2003 (2)
CPJ 160 (NCDRC)]. In another judgment by the Madras High Court in Aparna Dutta v. Apollo
Hospitals Enterprises Ltd. [2002 ACJ 954 (Mad. HC)], it was held that;
" it was the hospital that was offering the medical services. The terms under which the
hospital employs the doctors and surgeons are between them but because of this it cannot
be stated that the hospital cannot be held liable so far as third party patients are
concerned. It is expected from the hospital, to provide such a medical service and in case
where there is deficiency of service or in cases, where the operation has been done
negligently without bestowing normal care and caution, the hospital also must be held
liable and it cannot be allowed to escape from the liability by stating that there is no
master-servant relationship between the hospital, and the surgeon who performed the
operation. The hospital is liable in case of established negligence and it is no more a
defense to say that the surgeon is not a servant employed by the hospital, etc."
In the instant case, the hospital OP-2 is vicariously liable for the wrongs of OP 3,4 and 5.
Compensation:
31. Adverting to the extent of compensation, the complainants had prayed for the total
compensation of Rs.1,30,25,000/-. In this context, we rely upon several judgments of Hon''ble
Supreme Court like Reshma Kumar and Ors. Vs. Madan Mohan and Anr. (2009) 13 SCC 422,
Nizams Institute of Medical Sciences Vs. Prasanth S. Dhananka and Ors. (2009) 6 SCC 1 and the
recent judgment in Balram Prasad Vs. Kunal Shah and Ors. (2014) 1 SCC 384.
The Hon''ble Supreme Court in Nizams Institute of Medical Sciences Vs. Prasanth S.
Dhananka and Ors. (2009) 6 SCC 1 held that;
We must emphasize that the court has to strike a balance between the inflated and
unreasonable demands of a victim and the equally untenable claim of the opposite party
saying that nothing is payable. Sympathy for the victim does not, and should not, come in
the way of making a correct assessment, but if a case is made out, the court must not be
chary of awarding adequate compensation. The adequate compensation that we speak of,
must to some extent, be a rule of thumb measure, and as a balance has to be struck, it
would be difficult to satisfy all the parties concerned.
In Balram Prasad Vs. Kunal Shah and Ors . (2014) 1 SCC 384, the Honble Supreme Court
has again emphasized that it is the duty of the Tribunals, Commissions and the Courts to
consider relevant facts and evidence in respect of facts and circumstances of each and
every case for awarding just and reasonable compensation.
32. In this instant case, the facts and findings are similar, the negligence and deficiency in
service is proved against OP2 to 5. Considering the entirety, we follow the decision of the bench
of Hon''ble Mr. Justice J. S. Khehar and Hon''ble Mr. Justice S. A. Bobde of Apex Court in the
case of V.Krishna Kumar Vs. State of Tamil Nadu & Ors. JT 2015 (6) SC 503. Hon''ble Mr.
Justice S.A. Bobde awarded compensation of 1.38 Crores considering the apportioning for
inflation and apportionment of liability.
33. The child, Master Rishabh, has been rendered blind for life. The darkness in his life can never be really compensated for, in money terms. Blindness can have terrible consequences. The family belongs to the middle class, which incurred expenses on the child. The father is no more. Undoubtedly, the care of visually disabled child needs reasonable spells of time. Master Rishabh may also face great difficulties in getting education, marriage and social life. It is, thus, obvious that there should be adequate compensation for the pain and suffering, and the future care that would be necessary while accounting for inflationary trends. Almost one decade has elapsed during treatment and the litigation; certainly the complainants incurred huge expenditure. It is, therefore, necessary to consider the loss which Master Rishabh and his parents had to suffer and also to make a suitable provision for Rishabh''s future. It is pertinent to note that, the father of child Kuldeep Sharma was working as temporary employee in MCD, New Delhi. He expired during pendency of this case. Hence, the complainant 2, the mother of Master Rishabh, is a home maker. She will have to take care of entire family including her two kids. Therefore, we assume that, for an average middle class family, yearly expenses will be to the tune of Rs.200,000/-, out of which Rs. 50,000/- would be a need for Master Rishabh''s living including medical expenses.
34. As observed in V. Krishnakumar''s Case, Inflation over time certainly erodes the value of money. The rate of inflation (Wholesale Price Index-Annual Variation) in India, presently, is 2 percent 4 as per the Reserve Bank of India. Therefore, having considered the present economy and medical inventions, the child may need treatment in future. Master Rishabh''s present age is about 11 years. If his life expectancy is taken to be about 70 years, for the next 59 years. The average inflationary rate between 1990-91 and 2014-15 is 6.76% and 2015-16 is 5.65% as per data from the RBI. In the present case, we are of the view that this inflationary principle must be adopted at a conservative rate of 1 percent per annum to keep in mind, fluctuations over the next 59 years. The amount of expenditure, at the same rate will work out to be Rs.53,06,193.32/- rounded to Rs.53,00,000/- by applying formula for Apportioning for Inflation as FV = PV x (1+r)n ( PV = Present Value = 50,000, r = rate of return = 1.01, n = time period = 59)
35. Compensation to mother:
Hon''ble Supreme Court, in Spring Meadows Hospital and Another v. Harjol Ahluwalia [1998
4 SCC 39] this court acknowledged the importance of granting compensation to the parents of a
victim of medical negligence in lieu of their acute mental agony and the lifelong care and
attention they would have to give to the child. This being so, the financial hardships faced by the
parents, in terms of lost wages and time, must also be recognized. Thus, the above expenditure
must be allowed. It is true that, the mother Smt. Pooja Sharma has to take care of the blind child,
throughout her life. She has to suffer mental agony and social stigma due to visually disabled
child. Therefore, we are of considered view that, an award of sum of Rs.10,00,000/- to the
mother(complainant No.2) is just and proper.
36. Therefore, on the basis of the aforementioned discussion, the relevant medical literature and
decisions of Hon''ble Supreme court on medical negligence, we allow this complaint and fix the
liability for total sum of Rs.63 lacs( 53L+10L) upon the OPs 2 to 5. Further we impose
Rs.1,00,000/- toward costs of litigation.
37. For the reasons stated herein above, we direct the OP 2 to 5 to pay Rs. 64,00,000/- (64 lacs), to the complainants jointly and severally within 2 months from the date of receipt of this order, failing which, entire amount will carry the interest @ 9% per annum from today i.e date of pronouncement till its realisation. It is further directed that, out of the total compensation, Rs.50,00,000/- to be kept in fixed deposit in any Nationalised Bank, in the name of Master Rishabh Sharma till he attains the age of 21 years. The periodic interest shall be paid to the mother for 21 years. The remaining amount of Rs. 14 lacs be paid to the Smt Pooja Sharma (Complainant No 2), the mother of Master Rishabh.
A copy of this order as per the statutory requirements be forwarded to the parties free of charge.
List for compliance on August 1,2016.