National Consumer Disputes Redressal
Ruben Banerjee vs Ehirc Heart Institute And Research ... on 20 December, 2007
Equivalent citations: I(2008)CPJ239(NC)
ORDER
P.D. Shenoy, Member
1. This is a case of alleged medical negligence against EHIRC Heart Institute and Research Centre (hereinafter referred to as "EHIRC"), New Delhi and its Doctors in treating 2 years girl child suffering from Cyanotic Congenital Heart Disease.
Case of the complainant:
2. The complainant is the father of the Baby Rahi who was born on 8.6.1994. On 15th August, 1996 family members suspected heart problem when her fingertips became blue and hence was taken immediately to a paediatrician who suggested Echo Cardiogram which was done at B.M. Birla Heart Research Centre at Calcutta and found that Rahi was suffering from congenital heart disease. Doctors of the Centre suggested that the child needed to go through a series of surgeries. After conducting a survey of the hospitals, complainant decided to take Rahi to EHIRC at Delhi. Complainant went to Delhi along with Echo Cardiogram report and relevant blood reports and met Dr. Krishna Iyer, the Paediatric Surgeon on 12.9.1996 who after perusal of the reports asked him to meet Dr. Savitri Shrivastava, Senior Consultant Cardiologist. On going through all the reports Dr. Shrivastava suggested that the baby should undergo Cath. On 17.10.1996 she underwent cardiac catheterization and angiography. She was discharged from the hospital on 18.10.1996 with advice to get readmitted on 24.10.1996 for surgery. On 24.10.1996 Rahi had apparent symptoms of common cold and cough. Prior to admitting her, complainant took her to OPD and showed her to Dr. K. Iyer. Dr. Parvati Iyer wife of Dr. K. Iyer who was present at that time, prescribed Triaminic syrup and Sporidex 250 till 28.10.1996 and she was advised admission on 28.10.1996. In addition to the deposits made earlier, on 28.10.1996 complainant made deposit of Rs. 1,15,000 at the time of admission. The next day i.e. 29.10.1996 Phlebetomy was done for checking haemoglobin level. Two days later she was discharged without surgery. The discharge summary signed by Dr. Mridul Sharma, Senior Resident Cardiologist and Dr. Savitri Shirvastava, Senior Consultant indicated that the patient was admitted for surgery which was postponed in view of URTI (Upper Respiratory Tract Infection). It was suggested in the summary that patient should be readmitted for surgery on 23.11.1996, Rahi along with the complainant's wife flew to Calcutta on 1.11.1996 and the patient died on the next day. The death certificate stated that she died due to Broncho Pneumonia. It was alleged that since Rahi had URTI in EHIRC it should have given specific medicine for treating the infection and kept her in the EHIRC itself, which was not done. The hospital retained the balance amount of Rs. 1.08 lakh. At the time of discharge the doctors should have prescribed medicines/ antibiotics for treating URTI. What they prescribed were Cecon drops and Tonoferon drops. Cecon is nothing but Vitamin C and Tonoferon is iron, which by no stretch of imagination can be considered as any medication for treating URTI. As the child was not treated properly for URTI, which led to Broncho Pneumonia and became fatal for the child leading to her death within 48 hours of discharge. Broncho Pneumonia is LRTI (Lower Respiratory Tract Infection). Accordingly, he filed a complaint against the opposite parties for medical negligence since they-
(a) failed to use reasonable degree of care,
(b) made error of judgment while treating the patient.
(c) made grave mistakes in not prescribing the proper medicine to control URTI.
They claimed a compensation of Rs. 20 crores from the opposite parties 1 to 5.
Case of the opposite parties:
3. The opposite parties submitted a written statement stating that baby Rani was not a normal child as she was born with a complex (CHD) cyanotic congenital heart disease (commonly known as 'Blue Baby'). Two out of four valves of the heart were malformed and were malfunctioning. Main pulmonary artery i.e. the artery carrying blood to the lungs from the heart was malformed which in medical terminology is known as 'Pulmonary Atresia with Intact Ventricular Septum' which is a highly lethal mal-formation and about 50% of the patients suffering from this disease die within two weeks of birth and above 80% die by the age of 6 months if the same is not treated. It may be noted that the only and most efficacious treatment available for such abnormality is multiple surgeries. In such a disease death is caused by severe hypoxia (deficiency of oxygen supply to the body tissues) and metabolic acidosis (the presence of acids in the blood beyond the normal limits). Surgery carries considerable risk, as even after surgery there is only 25% to 40% chance of survival, up to the age of 10 years. Current medical practice is to operate upon such children in the very first years of their lives, as delay causes complication like deranged clotting ability of the blood increasing the risk of surgical procedure e.g., bleeding at multiple sites during surgery. Accordingly, Phlebotomy, a recommended medical practice was advised to the complainant to bring down the high haemoglobin content in the body so as to improve the blood clotting system. For the patient suffering from this congenital disease, surgery and subsequent treatment is only palliative in nature and not a complete cure. In other words treatment can only assist in prolonging their lives that too after repetitive surgeries but such patients will not be able to lead a normal healthy life. As the baby was suffering from running nose with yellow discharge for which she had already been prescribed a broad spectrum antibiotic, namely Sporidex by the Calcutta Institute, the same was recommended to be continued and further for nasal decongestion Triaminic syrup was prescribed to the patient. On 28.10.1996 baby Rahi was readmitted to EHIRC but as it was observed that she was still on a running nose, surgery had to be deferred. The blood test and chest x-ray taken during this week did not show any evidence of either any bacterial infection or Lower Respiratory Tract Infection (LRTI), also known as Broncho Pneumonia.
4. Baby Rahi was admitted in EHIRC on 16.10.1996. Echo-cardiogram, Cardiac Catheterization and Angiography were done on 17.10.1996, which revealed "Pulmonary Atresia with Intact Intra-ventricular Septum, Patent Arterial Duct, Left Pulmonary Artery Stenosis at origin and Right Ventricle Dependent Coronary circulation" for which the treatment recommended was "Bi-directional Glenn and P.A. Plasty". The surgery of baby Rahi was deferred in the best interest of the child as her surgery/being a high risk surgery, due to late presentation and thus the chronic blueness had to be attended to under optimal conditions for a good outcome. When baby Rahi was discharged on 31.10.1996 she did not have any evidence of Broncho Pneumonia. Opposite parties are at a loss to understand as to how the diagnosis of Broncho Pneumonia was made by the doctor at Calcutta as alleged in the death certificate. The chest x-ray dated 28.10.1996 and the blood test taken at EHIRC showed no evidence of even a brewing Broncho Pneumonia. Doctor who issued the death certificate is not a qualified pediatrician and had not made any references to the basis on which he has arrived at this conclusion. There are no specific medicines for the treatment of URTI (common cold). The internationally renowned text book of Paediatrics by Ruldoph clearly confirms the aforesaid facts. The ongoing treatment of Sporidex (antibiotic) and Syrup Triaminic (decongestant) was continued during her three days stay in the hospital. In this case as the child had already started Sporidex on presentation on 24th October, it was considered advisable to continue the same for the full course as discontinuation of antibiotic before completion of a full course of 7 days is medically inadvisable. URTI is normally managed on an out-patient basis. However, due to parental anxiety baby Rahi was retained in the hospital for 3 days and kept under observation and thereafter the complainant was given the option of staying in Delhi so that the child would be under observation from time-to-time and that the child could be operated immediately when the common cold condition of the child had completely cured.
Submissions of the learned Counsel for the complainant:
5. Mr. S.K. Ghosh, learned Counsel for the complainant submitted that the WHO guidelines are against the use of antibiotics in URTI.
6. Learned Counsel referred to an extract from Nelson's Textbook of Pediatrics--(Fourteenth Edition) which is as follows:
URTI Infection: Most viral infections of the upper respiratory tract also involve the lower respiratory tract, and in many cases pulmonary function diminishes even though lower respiratory tract symptoms are inconspicuous or absent. On the other hand, typical laryngotra-cheobronchitis, bronchiolitis, or pneumonia may develop during the course of acute nasopharyngitis. Viral nasopharyngitis is also a frequent trigger for asthma symptoms in children with reactive airways.
Prevention: Effective vaccines are not available. Neither gamma globulin nor vitamin C reduces the frequency, or severity of infections, and their use is not recommended.
Treatment: There is no specific therapy. Antibiotics do not affect the course of the illness or reduce the incidence of bacterial complications, Bed rest is generally recommended, but there is no evidence that it shortens the course of the illness or affects the outcome.
The death certificate given by Dr. S.N. Roy who j is an experienced cardiologist has stated that the cause of death is "Severe Cyanotic Heart Disease (Pulmonary Atresia) with Broncho Pneumonia."
7. The discharge summary says that the patient was admitted for surgery, which was e postponed in view of URTI. Phlebotomy (100 ml of blood) was done on 29.10.1996. The procedure was uncomplicated and well tolerated. Her subsequent stay in the hospital was uneventful. Condition at discharge is stable. Plan for continued care was by bi-directional f Glenn with PA Plasty, to get readmitted on 23.11.1996 for surgery. Recommended medication was Cecon 1/2 ml. once daily. Tonoferon 5 drops twice daily. There is no mention in the discharge summary that child should be retained at Delhi and to be brought to the hospital for regular checkup. There is also no mention that child was discharged against advice. There is no further mention that URTI was resolved at the time of discharge.
8. The treatment record of the EHIRC indicates on 20.8.1996--status-post cath, admitted for surgery. On antibiotics for URI since 17.10.1996, at present mild running of nose, afebrile chest clear. Advice--continue antibiotics. He averred why antibiotics were continued when it is not recommended for common cold. Similarly when the patient was discharged chest was clear. Why the patient was discharged when the chest was clear? Why surgery was not performed?
Mr. Ghosh quoted an extract from the following medical text: Second Edition of Pediatric Cardiac Anaesthesia by Carol L. Lake-
Viral Infection: Post-operative pulmonary infection is a dreaded complication. Viral upper and lower respiratory tract infections are common in all children, particularly in the first year or two of life, so it is not surprising that this is of major importance in post-operative care. Such infections can be devastating in child with congenital heart disease.
9. He quoted the Manual for Doctors and Other Senior Health Workers published by WHO under a programme for the control of Acute Respiratory Infections in children. "Case management of acute upper respiratory infections--reduce the inappropriate use of antibiotics for respiratory infections (most respiratory infections are due to the common cold and will not benefit from antibiotics). This is an important objective of national ARI control programmes, because it will retard the development of antibiotic resistance and conserve resources.
The guidelines discourage inappro-priate antibiotic use for children with very common but usually benign respiratory infections. These include the common cold, purulent nasal discharge, pharyngitis in young children, and bronchitis. Administering antibiotics for these common conditions, or for fever alone (with no other signs of serious infection), would result in their very widespread use without benefit and with a substantial risk of side effect and increased antibiotic resistance. Antibiotics should not be used for upper respiratory infections to try to prevent them from developing into bacterial pneumonia."
10. He quoted from the affidavit of the complainant Ruben Banerjee, father of the deceased--"Baby Rahi did not die because of the so-called 'risks' involved in the surgery. She died because the doctors at the EHIRC did not treat her properly for her URTI and did not carry out the surgery. She died because of medical negligence and apathy by the doctors at the EHIRC."
11. He quoted the judgment of the Apex Court in Savita Garg (Smt.) v. Director, National Heart Institute , is applicable in this case. The Apex Court observed that:
Once a claim petition is filed and the claimant has successfully discharged the initial burden that the hospital was negligent, and that as a result of such negligence the patient died, then in the case the burden lies on the hospital and the doctor concerned who treated that patient, to show that there was no negligence involved in the treatment. Since the burden is on the hospital, they can discharge the same by producing the doctor who treated the patient in defence to substantiate their allegation that there was no negligence. It is the hospital which engages the treating doctor, thereafter it is their responsibility. The burden is greater on the institution/hospital than that on the claimant. In any case, the hospital is in a better position to disclose what care was taken or what medicine was administered to the patient. It is the duty of the hospital to satisfy that there was no lack of care or diligence. The institution is a private body and it is responsible to provide efficient service and if in discharge of its efficient service there are a couple of weak links which have caused damage to the patient, then it is the hospital which is to justify the same and it is not possible for the claimant to implead all of them as parties.
Submissions of the Senior Advocate for the respondent:
12. Ms. Indu Malhotra submitted that EHIRC did not conduct surgery. The complainant himself had not stated that Baby Rani died due to surgical complication. The allegation is that no surgery was done in time because the doctors at EHIRC were negligent. Baby Rahi was brought to EHIRC after much delay with a complicated congenital heart problem. She was born with several deformities. Even after congenital heart disease was detected in August 1996 at B.M. Birla Heart Research Centre wherein it was recommended that the Baby required series of surgeries but she was brought after two months only to EHIRC, for the first time. As the patient was suffering from cold--surgery had to be postponed. The death could not have occurred on 2.11.1996 on account of Broncho Pneumonia as contended by the complainant.
13. Ms. Malhotra quoted the Covernment of India guidelines for the diagnosis of Pneumonia thus:
Pneumonia is recognized by increased respiratory rate. The severity of Pneumonia is recognized by chest indrawing. These signs have been found to be as specific and more sensitive than auscultation for the purposes of Pneumonia.
IN A CHILD WITH COUGH OR DIFFICULTY IN BREATHING
--Fast breathing indicates Pneumonia.
--Fast breathing and chest indicate severe Pneumonia.
--Chest indrawing even when present alone also indicates severe pneumonia".
...
instability to take fluids, excessive drowsiness, presence of convulsions, cyanosis and apnoea are signs of very severe illness.
As per WHO Guidelines:
The WHO Protocol for the detection of young children with Pneumonia examines children with a cough or difficult breathing for fast breathing, chest indrawing and signs of very severe disease and classifies most of them as not having pneumonia. The mother is advised to give supportive care at home and bring the child back if s/he worsens, is not able to drink, or develops fast or difficult breathing In the present case, baby Rahi did not have any of the aforesaid symptoms on 31.10.1996 at the time of Discharge.
14. Broncho Pneumonia does not develop overnight and cause sudden death. To the contrary the x-ray report dated 28.10.1996, the blood test and other pathological tests do not show any presence of any bacterial infection.
15. On 31.10.1996 in the Progress Note the patient's condition was recorded as:
Stable HR 144/mnt. Afebrile. No running of nose. Chest clear.
There were no symptoms whatsoever of Broncho Pneumonia on 31.10.1996 at the time of Discharge from EHIRC.
The baby expired at 5.30 p.m. on 2nd November, 1996. As per Death Certificate the cause of death is:
Severe Cyanotic heart disease (Pulmonary Atresia) with broncho pneumonia.
Ms. Malhotra submitted that the respondents are disputing the Death Certificate inasmuch as it states that the death was inter alia caused by Broncho Pneumonia. Doctor who issued the Death Certificate had not seen the patient before death. The Death Certificate has not been exhibited, nor has the Doctor filed an affidavit to prove the Certificate. No evidentiary value can be attached to it. No post-mortem done to ascertain the exact cause of death.
16. In the present case Baby Rahi did not have any of the aforesaid systems on 31.10.1996 at the time of discharge. Broncho Pneumonia does not develop overnight and cause sudden death. X-ray report dated 28.10.1996 did not show any presence of bacterial infection. The patient's condition at the time of discharge noted that stable HR 144/mnt. Tine baby was given Triaminic syrup and Sporidex 250 till 31.10.1996 but it is alleged that respondents have over-medicated her. Two out of the four valves of the baby were not functioning. Baby could not have been operated when she was suffering from URTI. She read out the treatment records from 20.10.1996 till time of discharge:
-----------------------------------------------------------------------------------EHIRC EHIRC No. 96/707023
Heart Institute Name: Baby Rahi Banerjee
And Age/Sex : 2 yrs.
Research Centre Ward/Bed : 403
Reg. No.:
-----------------------------------------------------------------------------------
PROGRESS/ INVESTIGATION/ PROCEDURES
-----------------------------------------------------------------------------------
DATE/TIME Status - Post Cam, admitted for surgery
25.10.1996 On antibiotics for URI since 17.10.1996
At present mild running of nose, afebrile, chest clear
Adv. Continue antibiotics
Send blood for pre-op investigations
29.10.96 Blood reports available : Hb 19.6 counts normal.
Running nose - less. Afebrile, Chest clear
Adv. Phlebotomy
Ct. antibiotics
5 p.m. Phlebotomy done in ICW with 75 ml blood drawn and replaced
e 75ml FFP
Child tolerated the procedure well. Stable AR 130/mn
Plan : Shift to ward
Rpt HCT tomorrow
Ct antibiotics
30.10.96 Stable Marked decrease in running of nose. Afebrile
Chest clear HR124/min. Hb 18.3 test 50
Adv. Ct. antibiotics
31.10.96 Stable HR 144/mnt. Afebrile. No running of nose
Chest Clear
Adv. Ct. Antibiotics
Discussed with father. In view of resolving cold it was
considered prudent to defer surgery for at least 2 weeks.
Decongestants and antibiotics ceased in absence of any
continued indication.
------------------------------------------------------------------------------------
Ruben Banerjee, father of the deceased has not filed any affidavit by way of evidence. He has only filed an affidavit by rejoinder. Baby Rani's treatment started at Calcutta wherein she was recommended Sporidex 250, EHIRC found it to be proper to continue this treatment. The baby did not suffer from bacterial infection at the time of discharge to cause any Broncho Pneumonia.
Rejoinder submissions by learned Counsel for the complainant:
17. Mr. Ghosh submitted that this is not a case of over-medication but improper medication. Hospital records were not available and they were given only after the complaint was filed.
Findings:
18. Baby Rahi was not a normal baby and she suffered from several congenital defects. She was shown to a pediatrician who suggested Echo Cardiogram which was done at B.M. Birla Heart Research Centre at Calcutta after her birth by her parents wherein following deformities are indicated:
--Complex Cyanotic Congenital Heart Disease
--Pulmonary Artresia with intact ventricular septum
--Patent ductus arterosis
--Right ventricular Hypoplasia with tricuspid valve hypoplasis
--LPA stenosis
--High Haemoglobin 19.6 gms. (normal count is ll-14gms.)
--Continuous murmur was audible at 2nd and 3rd LICS and along the spine
--Oxygen saturation of blood was 64% (normal is 97-100%) Further when the baby was brought to EHIRC the treatment records indicate the following diseases:
* Complex Cyanotic Congenital heart disease * Situs Solitus * AV concordance VAconcordance * Pulmonary atresia with intact ventricular septum * Patent ductus arteriosis * Patent ductus arteriosis * Right ventricular hypoplasia with tricuspid valve hypoplasia * LPA stenosis Naturally it was necessary for the team of doctors who took care of her at EHIRC to be extremely careful as she required multiple surgeries. Prior to her visit to EHIRC she was diagnosed as suffering from congenital heart disease at B.M. Birla Heart Research Centre on 22nd August, 1996. This Research Centre suggested that Rahi needed to go through a series of surgeries. The complainant collected the information about various health institutions/hospitals in India and abroad and zeroed in on EH IRC, New Delhi for the surgical treatment. As the baby was suffering from URTI Sporidex (antibiotic) which was prescribed by Birla Centre was continued.
19. According to the hospital authorities the surgery of baby Rahi was deferred in the best interest of the child as her surgery was a high risk surgery owing to late presentation and chronic blueness, the surgery had to be performed under optimal conditions for a good outcome. Hospital records indicate that at the time of discharge on 30.10.1996 the treating doctors discussed the case with the father of the baby. In view of the resolving cold it was considered prudent to defer surgery for at least two weeks. Hence, it is difficult to hold that the doctors of the hospital were negligent in deferring the surgery.
20. In the medical text on Pediatric Cardiac Anesthesia, Second Edition by Carol L. Lake it is written as follows:
Viral infection: Posto-perative pulmonary infection is a dreaded complication. Viral upper and lower respiratory tract infections are common in all children, particularly in the first year or two of life, so it is not surprising that this is of major importance in posto-perative care. Such infections can be devastating in child with congenital heart disease.
As much as possible, children should be isolated from others with viral infections both before and after surgery. Surgery should probably be delayed in the presence of a viral upper respiratory infection (URI).
It is true that learned Counsel for the complainant had quoted the medical text to show that effective vaccines are not available for prevention of common cold or upper respiratory tract infection. Neither gamma globulin nor vitamin C reduces the frequency or severity of infections, and their use is not recommended. But he has not shown any medical text showing that what other medicine should be given in lieu of Vitamin C and iron. The quoted medical text also mentions for proper case management of upper respiratory tract infection doctors should reduce inappropriate use of antibiotics for respiratory infections (supra) which has been done in this case. Further, no evidence of any expert doctor has been produced in support of the contentions of the complainant.
21. The death certificate given by Dr. S.N. Roy indicates that the child died due to 'Severe Cyanotic Heart Disease (Pulmonary Atresia) with Broncho Pneumonia'. This certificate was issued by a cardiologist. The main cause of the death is mentioned as Severe Cyanotic Heart Disease which the patient was suffering from birth. The other cause has been mentioned as Broncho Pneumonia. There is no record before us that this doctor has treated or seen the patient prior to the death. How he has come to the conclusion that the death is due to Broncho Pneumonia remains unexplained. Further this doctor has not filed any affidavit. There was no post-mortem conducted to support this certificate. Hospital records prior to death at the time of discharge did not indicate that the child was suffering from Broncho Pneumonia. Accordingly we cannot attach any importance to the death certificate.
22. The learned Advocate for the complainant has quoted the judgment in Savita Garg case. This citation is not applicable to this case for the following reasons:
(a) The complainant has not successfully discharged the initial burden that the hospital is negligent.
(b) The patient did not die in the hospital.
(c) The treating doctors and their names were well known to the complainant and they have been already impleaded as the opposite parties along with hospital in this case.
In view of the above analysis, we do not see any merit in this complaint. Accordingly, we dismiss the complaint. There shall be no order as to costs.