National Consumer Disputes Redressal
Master Vaibhav Apurva Vohra vs Sunil J. Parikh on 12 December, 2017
NATIONAL CONSUMER DISPUTES REDRESSAL COMMISSION NEW DELHI CONSUMER CASE NO. 58 OF 2003 1. MASTER VAIBHAV APURVA VOHRA Through His Father Dr. Apurva Vohra.,
R/o. P/1 Morya Palace,
5/1 Diamond Colony, New Palasia, Indore Madhya Pradesh ...........Complainant(s) Versus 1. SUNIL J. PARIKH Parekh House.,
14, Mamma Parmanand Marg., Mumbai - 400 004. 2. BOMBAY HOSPITAL AND MEDICAL RESEARCH CENTRE Through Its Medical Superintendent., New Marine Lines Mumbai 3. JASLOK HOSPITAL AND RESEACH CENTRE Through its Directord., 15, Dr. G. Deshmukh Marg. Mumbai - 400 026. ...........Opp.Party(s)
BEFORE: HON'BLE MR. JUSTICE AJIT BHARIHOKE,PRESIDING MEMBER HON'BLE MR. DR. S.M. KANTIKAR,MEMBER
For the Complainant : Mr. K.P. Toms, Advocate For the Opp.Party : For the Opp. Party No.1 : NEMO
For the Opp. Party No.2 : Mr. Dileep Poolakkot, Advocate
For the Opp. Party No.3 : Mr. Sanjeev Mahajan, Advocate Alongwith Ms. Shweta Priyadarshini, adv.
Ms. Shweta Priyadarshini, Advocate
And Mr. Satyam Dwivedi, Advocate
Dated : 12 Dec 2017 ORDER
DR. S. M. KANTIKAR, MEMBER
The Facts:
1.The complainant, Master Vaibhav Apurva Vohra, since minor, (herein after referred as 'the patient') was represented by Dr. Apurva Vohra. On 12.6.2001 Master Vaibhav, the patient was diagnosed for severe Idiopathic Aplastic Anemia (for short "Aplastic Anemia- AA") by Dr. Sunil J. Parikh/OP 1. Patient was admitted in Bombay Hospital & Medical Research Centre (for short 'Bombay Hospital'-OP-2) on 12.6.2001. Based on the diagnosis as AA, OP-1 started with Anti Lymphocyte Globulin (ALG) therapy for the patient. The ALG therapy was expensive, costing approximately Rs. 2 to 3 lakhs. The patient was hospitalized for 25 days. After the discharge, on 3.7.2001, patient was taken to home town Indore. Patient took supportive therapy at Bhandari Hospital and Research Centre at Indore. Thereafter, after gap of four months, patient approached OP-1 on 8.11.2001 and on the same day, OP-1 performed 2nd bone marrow biopsy, which revealed 'Persistent Hypoplasia of bone marrow.' Thus, there was marked improvement after ALG Therapy. Further, OP-1, to rule out Fanconi's Anemia (for short, 'FA'), advised Chromosomal breakage study. Accordingly, on 8.11.2001, OP-1 collected and sent blood samples to Jaslok Hospital/OP 3. It was alleged that, even though, patient was responding to ALG therapy, OP-1 unnecessarily insisted upon another test to rule out Fanconi's Anemia. On 28.11.2001, OP 3 issued a report stating that the patient was having Fanconis Anemia, therefore, OP-1 abruptly stopped ALG therapy and started different line of treatment with Anabolic steroids from 25.12.2001 till 23.4.2002 (five months). But, due to change in treatment, patient's health condition further deteriorated , which became out of control of OP-1. Then, OP-1 referred the patient to Hammersmith Hospital, London, U.K. for further opinion and treatment.
2. At Hammersmith Hospital ,UK patient was investigated and Chromosomal studies were also performed. The diagnosis of FA was ruled out, and AA was confirmed. Accordingly, second course of ALG plus Cyclosporine was recommended, which was the same treatment administered in India. The parents were extremely shocked to know that OP 1 wrongly diagnosed Fanconi's anemia. It was alleged that, before referring the patient to UK, OP-1 should have advised other family members for Chromosomal study to know genetic status. The complainants suffered huge financial loss and mental agony. It was further alleged that, the child/patient was unnecessarily given the anabolic steroids for five months which has a great potential side effect on the health of the child like, feminization, impotence, shrinkage of testicles, reduction in sperm count, development of breasts, difficulty or pain while urinating etc. Also, chances of rapid weight gain, liver damage and pre-mature heart attack or stroke are common. The child may also develop Psychological changes such as depression, irritability and aggression. The complainant has placed reliance on medical literature in this regard. The complainant submitted that the child manifested hirsuitism and weight gain. Due to alleged medical negligence on the part of treating doctor, the complainant filed a complaint before this Commission and prayed for compensation from all the OPs jointly and severally for a sum of Rs.1,38,06,000/- along with costs.
DEFENSE
3. The OPs filed written versions and denied the allegations of negligence, further submitted that the complaint is a complicated matter as it involves intricate questions of medical facts and law, therefore, it cannot be decided in summary manner. The OPs filed their respective affidavits of evidence separately.
Defense of Dr. Sunil J. Parikh (OP -1) In defense, OP-1 submitted that he is a qualified hematologist and practicing for more than three decades having his own clinic. He is attached with the Bombay Hospital(OP-2). The complaint was filed with mala fide intention. There was neither any deficiency in service nor any unfair trade practice. In his affidavit, OP-1 has explained about few medical terminologies like type of aplastic anaemia, Fanconi Anemia, the ALG and ATG therapies, also the utility of drug Cyclosporine. On 12.6.2001, after consultation with OP-1 patient was promptly hospitalized in OP-2. As per the history given by the parents of the patient, the patient had bleeding from the nose since April, 2001 and no treatment or any diagnosis was made till date. The initial blood tests values of patient revealed low values- viz Hemoglobin 3 g/dl, PCV (Hematocrit) 11%, White Blood count 2100/cmm, Platelets 5000/cmm . OP-1 performed Bone Marrow aspiration and biopsy and the test report was made available on 16.6.2001. Therefore, the patient was diagnosed as AA (idiopathic). During the intervening period supportive treatment and blood transfusion was given. Thereafter, for Aplastic Anemia, as a standard protocol specific triple immunosuppressive therapy was started at Bombay Hospital. Few other pediatricians were also consulted in this regard. From 19.6.2009 to 29.6.2009, for 10 days patient was given of ALG/ATG intravenously , along with oral Cyclosporine (Neoral) and oral Corticosteroids. During the treatment the complainant's parents were seeking discharge, but OP-1 did not recommend discharge. The parents were adamant; took premature discharge from OP-2 hospital on 3.7.2007, and patient was taken to his home town Indore. Thereafter, OP-1 had no control over the treatment and management of the patient. At Indore , patient was under treatment at Bhandari Hospital from 3.7.2001 to 30.10.2001, there was no hematologist. At the time of discharge OP-1 gave specific instructions to the parents to get tested blood Cyclosporine levels and Complete blood count twice a week and to give him regular update. Till 30.10.2001, patient never visited or consulted OP-1. Thus, the complainant himself was negligent, as he did not follow the instructions. After a gap of four months, on 8.11.2001 patient visited OP- 1. his vital parameters were below normal. OP-1 performed BM aspiration and BM biopsy. Similarly, OP-1 advised the patient to undergo Fanconi's test at Jaslok Hospital/OP 3 to rule out any possibility of Fanconi anemia, which may be the cause of aplastic marrow and his persistent low blood counts. The BM aspiration and biopsy revealed "Persistent Moderate Hypoplasia of Marrow, which indicated no complete improvement in the patient. The Jaslok Hospital/OP 3 performed Chromosome break-up studies and reported it as Fanconi's anemia. In Indore, for 4 months, patient was not monitored for the blood levels of Cyclosporine. Thus, to avoid serious side effects, OP-1 stopped Cyclosporine and started anabolic steroid from 24.12.2001. The OP-1 never agreed with the result of Jaslok Hospital/OP-3, therefore for further diagnosis and management, OP-1 advised the complainant to consult Dr. Dokal, at Hammersmith Hospital, UK, but instead of UK , the patient was taken to Indore.
4. The OP-1 further stated that the complainant had fully completed course of ATG/ALG in June, 2001. Even the treatment given in the form of anabolic steroid was a standard line of treatment which was followed internationally. Finally, on 2.4.2002, the patient was taken to Hammersmith Hospital, London to consult Dr. Dokal. After laboratory investigations, the possibility of Fanconi's was ruled out and Dr. Dokal advised same medication as prescribed by OP-1. Dr. Dokal also confirmed that the diagnosis and the treatment given by OP-1 was correct and accurate.
5. Defense of Bombay Hospital ( OP-2):
Mr. Siddeshwar De, General Manager (Legal) of OP-2, filed additional evidence on behalf of Bombay Hospital and contended that there was no cause of action or deficiency in service/negligence in the treatment of the patient from OP-2. The OP-2 is the premier institute in India having qualified specialists and super specialists in the concerned subject. On advice of OP-1, the patient was admitted in the hospital on 19.6.2001 for the course of Anti Lymphocyte Globulin (ALG) Therapy for a period of 10 days for the treatment of Idiopathic AA. The patient remained in OP 2/hospital for 25 days. During that period, the hospital provided medical services with reasonable care and caution under strict supervision of OP-1. On the instructions of OP-1, on 15.6.2005, HLA Tissue Typing Test was performed by using Plates of BIOTEST, GERMANY, that are used all over the world. He further submitted that the hospital has provided reasonable standard of care from its competent staff.
6. Defence of Jaslok Hospital and Research Centre (OP-3) Dr. Suresh Raghunandan Karnik filed an affidavit evidence on behalf of OP 3. He submitted that, there was no cause of action against OP- 3. The management of the patient and change in treatment was done by OP-1 and 2. There was no negligence or deficiency in service since role of OP-3 was limited to the extent to perform Mitomycin C (MMC) Chromosome stress test. The said test was conducted as per standard method with utmost care. OP-3 had analyzed more than 400 metaphases and on the basis of number of breaks in metaphases Fanconi's anemia was reported. The Hammersmith Hospital report also categorically does not state that ,the report of Jaslok Hospital was wrong. The Hammersmith Hospital, London, UK counted only 200 metaphases whereas doctor at OP-3 had counted 416 metaphases, and also provided with additional pictures of chromosome breakage and extreme fragmentation (pulverization). Thus, the report was not wrong. The possibility of Atypical type of Fanconi's Anemia cannot be ruled out. It might be possible due to mosaics, under such situations the subsequent test might turn out to be normal.
FINDINGS and REASONS:
7. We have given thoughtful consideration to the arguments advanced by both the parties. We have perused the voluminous medical record and medical literature filed by both the parties. To know about Aplastic and Faconi's anemia, we also took reference from few medical text books viz Wintrobe's Clinical Hematology (2013), The Merck Manual 'Approach to the Patient with Anemia'; Hematology: Basic Principles and Practice, Harrison's Hematology and Oncology( 2016), and the Nathan and Oski's Hematology and Oncology of Infancy and Childhood (2014). The complainant case was that, the child was initially diagnosed by OP-1 as idiopathic AA and hospitalized for 25 days in Bombay Hospital (OP-2). At the beginning only, the OP-1 failed to conduct the necessary tests to rule out possibility of FA, but test was done after lapse of four months. Thus it was deficiency on the part of OP-1. The test report as Fanconi's Anemia from Jaslok Hospital(OP-3) was erroneous. Even though, the patient had shown improvement after ALG therapy, but on the basis of report from OP-3, the ALG therapy was stopped by OP-1 and it was abruptly changed. Anabolic steroid was started which led to Hirsutisms and weight gain in the child. Due to negligent act of all the OPs, the complainant was compelled to take his child to Hammersmith Hospital, London, U.K. It incurred lot of medical expenses, mental agony. The complainant lost his professional income also.
8. It is an admitted fact that since April 2001 patient was suffering from repeated Epistaxis (Nasal bleed). In June, 2001, patient was taken from Indore to the clinic of OP-1 at Mumbai in critical condition. He was admitted in Bombay Hospital/OP-2 on 12.6.2001. At the time of admission all hematological parameters were very low, i.e. Hemoglobin 3 g/dl, PCV (Hematocrit) - 11%, White Blood Court was - 2100 / cmm and platelet count -5000 / cmm, thus patient was diagnosed as AA and initial supportive treatment and blood transfusion was given. OP-1 performed BM biopsy and confirmed the diagnosis of AA on 16.6.2001. Thereafter, OP-1 has started specific triple immunosuppressive therapy as a standard line of treatment, under round a clock supervision of Pediatricians. From 19.6.2001 to 29.6.2001, the patient was given ALG/ATG by infusion. Oral Cyclosporine (Neoral) and Oral corticosteroids were also given. At the request of the parents, on 3.7.2001, the patient was discharged from Bombay Hospital. He was discharged with strict instructions from OP-1 that, the patient should be kept in a separate room, record the temperature four times a day, regular blood counts and blood level of Cyclosporine. Thereafter, for 4 months i.e. till 30.10.2001, the complainant never visited Mumbai nor consulted OP-1 for further treatment. The parents continued the treatment on their own without any monitoring. On 8.11.2001, the patient visited OP- 1, with disoriented blood parameters, therefore, another BM aspiration and biopsy was repeated, which revealed "Persistent Moderate Hypoplasia of Marrow". Thus, the patient had not improved completely but only marginally improved. Therefore, to rule out the rare possibility of Fanconi's anemia, OP-1 advised MMC chromosomal breakage test, which was available with OP-3 at the relevant time. The OP-3 counted about 400 metaphase spreads and issued report as Fanconi's Anemia, but OP-1 never agreed with the report of OP-3. Accordingly, as an interim relief, OP-1 stopped ALG therapy and started Anabolic steroid and it was continued till the complainant approached Hammersmith Hospital, London. On 24.4.2002, at Hammersmith Hospital, Dr. Dokal examined the child and carried out certain tests and Chromosol breakage study. Dr. Dokal confirmed the diagnosis of AA and ruled out the possibility of Fanconi's anemia. Dr.Dokal advised ALG therapy as it was the same treatment given by OP-1. On 29.4.2002, the patient came back from U.K. and contacted OP 1, for further management.
9. We have perused the medical report from the department of Hematology, Hammersmith Hospital, London, U.K. It revealed that on 2.4.2002, the date of admission at Hammersmith Hospital, the patient was looking relatively well having slight cough. There were no symptoms. There was no mucosal bleeding. It was recorded that Vaibhav Vohra is very tall for his age. The other findings were normal. The report also stated that there was no evidence of Fanconi's Anemia, whereas Idiopathic Aplastic anemia diagnosis was confirmed, with the advice for Bone Marrow transplantation(BMT) in future, if any ALG Therapy fails.
10. Medical Literature:
We have perused the research articles and few standard medical text books on Hematology ( supra) for the diagnosis and treatment aspects of AA and FA. The relevant features are as below:
Aplastic anemia (AA) is a rare disease in which the bone marrow and the hemopoitic stem cells in the bone marrow are damaged. This causes a reduction of all three blood cell types i.e. Pancytopenia - Red Blood Cell(RBC)- Anemia, White blood cells(WBC)- Leukopenia and Platelets (Thrombocytopenia). Aplastic refers to inability of the stem cells to generate mature blood cells.
Aplastic anemia is an acquired disorder in more than 80% cases while the remaining 20% are inherited forms consisting of Fanconi anemia, dyskeratosis congenital and Schwachman syndrome. 'Idiopathic' aplastic anemia in which no cause is apparent accounts for approximately 65% of all cases of aplastic anemia It is most prevalent in people in their teens and twenties, but is also common among the elderly. It can be caused by heredity, immune disease, or exposure to chemicals, drugs, or radiation. However, in about half the cases, the cause is unknown.
The definitive diagnosis is done by Bone marrow biopsy. First line treatment for aplastic anemia consists of immunosupressive therapy, typically either Anti Lymphocyte Globulin(ALG) or Anti Thymocyte Globulin(ATG) , combined with Corticosteroids and Cyclosporine . Stem Cell Transplatation is also helful with related matched marrow donor.
Fanconi's Anemia(FA) is a rare genetic disease characterized by progressive bone marrow failure, malformations, and a high propensity of malignancies, including acute myeloid leukemia/myelodysplastic syndrome and squamous cell carcinomas Many cases of FA are not diagnosed at all or are not diagnosed in a timely manner. Anyone developing aplastic anemia at any age should be tested for FA, even if no other defects are present.
FA Cells usually exhibit spontaneous chromosomal breaks and rearrangements As the management of patients with FA differs from that of 'idiopathic' aplastic anemia, it is essential to differentiate these disorders at the earliest. to differentiate from Aaplastic anemia Mitomycin C (MMC) is used to analyze induced chromosomal breakage. The diagnosis of FA is made based upon a thorough clinical evaluation, a detailed patient history, identification of characteristic findings, and a variety of specialized tests. The definitive test for FA at the present time is a chromosome breakage test.
Treatment of Aplastic Anemia:
Some people are more likely to develop aplastic anemia because of their genetic (inherited) makeup. Fanconi's anemia is an inherited condition that causes aplastic anemia and also physical abnormalities. The patients with mild or moderate aplastic anemia may not need treatment as long as the condition doesn't get worse. The severe aplastic anemia patients need medical treatment right away to prevent complications. Very severe AA is fatal and the persons need emergency medical care in a hospital. Blood transfusions can help keep blood cell counts at acceptable The two main treatments for aplastic anemia that is severe and long-lasting are bone marrow transplantation and immunosuppressive therapies.
Some patients will be treated with immunosuppressive medications instead of bone marrow transplantation. These medicines include anti-thymocyte globulin (Thymoglobulin), known as ATG; antilymphocyte globulin (ALG); Prednisone (Deltasone, Orasone) and Cyclosporine (Neoral, Sandimmune, SangCya). Blood-cell production also can be stimulated with erythropoietin, granulocyte colony-stimulating factor (G-CSF), granulocyte-macrophage colony-stimulating factor (GM-CSF) or other hematopoietic growth factor medications. Corticosteroids, such as methylprednisolone (Medrol, Solu-Medrol), are often given at the same time as these drugs.
Most treatments for aplastic anemia require medications that severely impair the normal function of the immune system. This puts patients at risk for infections, often unusual ones.
A bone marrow transplant is the most effective therapy, but the possibility of dying from the treatment increases with age, so it is most ideal for children, adolescents and young adults.
11. Conclusion:
The crux of the present matter is whether the OP was responsible for any deficiency during treatment of the patient, which resulted in deterioration of health of the child and ultimately death. Looking into the sequence of events in the instant case, the child was brought to OP 1 in the month of June, 2001. Initially on clinical assessment and bone marrow study, OP-1 diagnosed it as Aplastic Anemia (idiopathic). Therefore, the proper line of treatment was immuno suppressive therapy alongwith supportive treatment. Initially, the patient was given blood transfusion. OP-1 started ALG Therapy for 10 days. According to the medical literature, OP-1 adopted correct method i.e. standard treatment in case of aplastic anemia. There are several causes of aplastic anemia, thus, it was the duty of OP-1 to rule out other causes of aplastic anemia. Accordingly, the patient's blood was tested from Jaslok Hospital/OP-3 to rule out Fanconi's Anemia. After chromosomal breakage study at OP-3, the report revealed Fanconi's Anemia. On the basis of this report, OP-1 stopped ALG therapy and started anabolic steroids. In our view, the efforts of OP-1 to rule out other causes of AA are acceptable. OP 1 did not agree with Chromosomal breakage study done by OP-3, with its diagnosis as Fanconi's Anemia. Therefore, he suggested that the patient seek further evaluation and management from Hammersmith Hospital at UK wherein Fanconi's Anemia was ruled out and AA was confirmed, thereafter same treatment of ALG therapy was recommended or bone marrow transplant was suggested. Thus, we do not find any fault with OP-1, who referred the patient to Hammersmith Hospital, U.K. Referring of the patient is not a negligence. In our view, it was a conscious effort of OP-1 to arrive at proper diagnosis.
12. Now, the question whether OP-3 was at fault for wrong diagnosis of FA. As per the evidence of OP-3, total 400 metaphases were counted before arriving the diagnosis of Fanconis Anemia. According to the medical literature, due to mosaicism, error can occur. Even the Hammersmith Hospital have not categorically ruled out possibility of Fanconi's Anemia and never said that the report of OP-3 was wrong. Therefore, in our view, OP-3 also performed his duty with care and caution. The interpretation of report was given on the basis of number of breaks in the chromosomal breakage studies by using MMC.
13. Now whether the stoppage of ALG therapy and administration of anabolic steroid by OP 1 from 24.12.2001 to 2.4.2002 caused any harm to the patient. There is no cogent evidence produced by the complainant to prove the side effects, which occurred in the child after steroid therapy. The medical literature states that the use of anabolic steroid in the treatment of aplastic anemia, has been proved to be very useful in children with congenital aplastic anemia.
14. Considering the entirety, in our view, the method adopted by OP-1 in the diagnosis, treatment and referral, was correct as per the reasonable and standard of medical practice. We do not find any negligence on the part of OPs.
15. The Hon'ble Supreme Court in the case of Dr. Laxman Balakrishna Joshi vs. Dr. Trimbak Bapu Godbole & Anr. AIR 1969 SC 128 and A.S. Mittal vs. State of U.P. AIR 1989 SC 1570, has laid down that when a Doctor is consulted by a patient, the former, namely, the Doctor owes to his patient certain duties which are (a) a duty of care in deciding whether to undertake the case; (b) a duty of care in deciding what treatment to give; and (c) a duty of care in the administration of that treatment. A breach of any of the above duties may give a cause of action for negligence and the patient may on that basis recover damages from his Doctor.
In the instant case, there was no deficiency or failure on duty of care from OP 1 during diagnosis, treatment and the referral.
16. Hon'ble Supreme Court in case "Jacob Mathew v. State of Punjab & Anr." AIR 2005 SCC 3180, held that, the complainant is required to prove that the doctor did something or failed to do something which in the given facts and circumstances, no medical professional in his ordinary senses and prudence would have done or failed to do.
In the instant case, the act of OP 1 was consistent with the professional tone, without any lapses.
17. On the basis of foregoing discussion and relying upon the medical literature and the legal precedents, we do not find any negligence on the part of OPs. The complaint is hereby dismissed. There shall be no order as to costs.
......................J AJIT BHARIHOKE PRESIDING MEMBER ...................... DR. S.M. KANTIKAR MEMBER