ORDER

DR. S. M. KANTIKAR, MEMBER

1.       These two cross First Appeals under Section 19 of the Consumer Protection Act, 1986 (for short “the Act”) arise out of the order dated 05.08.2014, passed by Delhi State Consumer Disputes Redressal Commission ( for short, “the State Commission”) in Complaint Case No. 113 of 2009. By the impugned order, while holding Opposite Parties guilty of medical negligence, the State Commission has directed the Opposite Parties in the Complaint to pay to the Complainants a sum of ₹ 7,50,000/-  for the suffering undergone by them; (ii) a sum of ₹ 2.5 lakh for medical expenses expended by them and costs quantified at ₹25,000/-. 

2.       While First Appeal No. 1009 of 2014 has been filed by the Complainants seeking enhancement of the compensation awarded,  First Appeal No.1084 of 2014 has been filed by the Opposite Parties for setting aside of the order and dismissal of the Complaint. Since both the cross Appeals arise from the same order, these are being disposed of by this common order.  However, the facts giving rise to the filing of this Complaint are drawn from First Appeal No. 1009 of 2014.

3.       On 03.09.2001, Sheela Srivastava, (since diseased, for  short, “the Patient”) was admitted in Rajiv Gandhi Cancer Institute and Research Centre (OP-1) (for short “the Hospital”). She was examined by Dr. K.K. Pandey (OP-2)/ the Chief of surgical Oncology. He diagnosed that she was suffering from  Carcinoma of right breast. On 05.09.2001, he performed mastectomy surgery.  The Patient was discharged from the hospital on 10.09.2001. Thereafter, the Patient underwent Radiotherapy; Interstitial breast implantation and interstitial brachytherapy under the supervision of Dr. S. Hukku (OP-3).  She was also given six cycles of Chemotherapy (for short ‘Chemo’) from 06.12.2001 to 21.03.2002, under the supervision of Dr. D. C. Doval (OP-4).  She was kept under periodic follow up.  However, she was having difficulty in eating and developed breathlessness and fatigue after minimal effort.  In July 2002, the Patient developed symptoms of nausea, and her breathlessness had also got intensified, she had to be admitted in the Hospital.

4.       After examination, she was diagnosed to be suffering from Congestive Heart Failure. There was drastic fall in the left ventricular ejection fraction (LVEF), which was below 30%, indicative of heart failure. The Complainants alleged that, the doctors in the Hospital had never informed them about the side effects of Chemo to which the Patient was subjected to; the doctors failed to undertake proper cardiac assessment prior to starting of Chemo; the Patient was not monitored during Chemo and Radiotherapy; her height was wrongly record  as 173 cm, whereas the actual height was 163 cm;  the difference of 10 cm height led to wrong calculation of Body Surface Area (BSA) and consequently  the dose of Adriamycin, thus it was on higher side; due to high dose of Adriamycin, the Patient lost considerable weight during Chemo, consequently resulting in reduction in BSA; at the end of six cycles, the weight of the Patient was reduced from 55 kg to 42 kg; the said weight loss was not noticed by OP-4 and hence the 6^th dose of Chemo was not adjusted according to the weight. Subsequently, in the month of July, 2002, the Patient suffered cardiac problem. On being approached OP-4 informed the Patient that it was a temporary side effect of cancer treatment and would get cured within short time by medication. The Patient was put on heavy doses of medicine to improve LVEF. Under these circumstances alleging deficiency and negligence on the part of the doctors working in the Hospital, in causing permanent disability of the heart, lungs and brain to the Patient, the complaint came to be filed by the Patient herself before State Commission claiming ₹ 71,50,000/- as  compensation for the mental and physical agony suffered by her. During the pendency of the complaint, the Patient/Complainant expired on 04.11.2013 and her legal representatives (LRs) were duly  brought on record.

5.       The Opposite Parties resisted the complaint. In their separate written versions, by way of preliminary objection, it was pleaded that the complaint was  barred by limitation, in as much as the Patient had taken treatment at the Hospital from year 2002 and her last visit to was in April 2004, whereas, the complaint was filed in  the year 2009, well beyond the limitation period of 2 years from the date  the cause of action had arisen.  On merits of the Complaint, it was averred that, though the breast tumor size was small, her tumour marker study  had  revealed Negative for Estrogen and Progesterone receptors (for short ‘ER and PR’) and over expression of HER-2 neu,  which was a high-risk breast cancer, hence she had to be given complete Radiotherapy (external radiation and brachytherapy boost) as per international protocol, to avoid recurrence of the cancer.  Further, six cycles of Chemo were recommended by the Medical Oncologist Dr.Devol (OP-4). The  Patient and her family members were informed about the adverse effect of Chemo and after obtaining the informed consent Chemo procedure was started: the total dose of Chemo was calculated on the basis of BSA of the Patient: As per calculation  dose of Adriamycin 60 mg/m²  and Cyclophosphamide 600 mg/ m² on  3 weekly for 4-6 Chemo cycles was decided. It was also pleaded that, ECG was performed before the surgery, which did not reveal any abnormality. Before the brachytherapy, ECG was performed again and it was found to be within normal limit. The   cardiology opinion was also taken before initiation of Chemo and she was found to be fit for Chemo. During the entire course of Chemo for 6 cycles, Patient was monitored and during every Chemo cycle, her vital parameters, blood pressure and pulse rate were normal.  As the Patient was asymptomatic and she did not show any side effects like breathlessness or chest pain or signs of CHF,  2D- ECHO for LVEF was not advised. In fact necessity of ECHO is only when the cumulative dosage of Doxorubicin reaches to 450 mg/m^2, the Patient tolerated Chemo well and during the entire Chemo cycles, Patient did not show any abnormality, except general weakness and poor appetite. During the last cycle she was found to be anaemic and was thus prescribed prophylactic G-CSF support and Packed RBC transfusion. Injection Recorman was also prescribed. The Hospital denied that attention was not paid  by the Oncology department during heart problems. According to OPs, on 12.7.2002, Patient was admitted in  the Hospital with the complaint of breathlessness; she was immediately attended to by a Cardiologist Dr. Pradeep Rastogi, who advised the treatment and after improvement, she was discharged on 20.7.2002. She was called for regular follow-up. Thus, the Patient was treated for her Cardiac problems as per the standard guidelines of American Heart Association for CHF.  Therefore, considered in entirety, there was no negligence on the part of either the treating doctors and the hospital. It was also pleaded that the fact that the Patient survived for more than 10 years after Chemo shows that the treatment given by the OPs was proper.

6.       On evaluation of the evidence adduced by the Parties in support of their respective stands, the State Commission allowed the complaint partially directing the Opposite Parties to pay to the Complainants the aforestated amounts. Hence, these cross Appeals.

7.       We have heard Learned Counsel for both the parties. Learned Counsel for the Complainants strenuously urged that Opposite Parties failed to record the correct height and weight of the Patient, she was administered wrong does of Adriamycin, which had adverse effect on the health of the Patient ultimately resulting in her death.  It was asserted that on the basis of height, the BSA was calculated and the dosage of Adriamycin was determined. The Counsel submitted that, as the height of Patient was recorded wrongly, as 173 cm instead of 163 cm; the calculated dose of Adriamycin was on the higher side. It was also submitted that, prior to the start of every Chemo cycle, the OP-4 had failed to check the body weight of patient.  At the end of 6^th cycle the weight of Patient had reduced by 13 kg but the reduction in weight was not considered by OP-4 in determining the correct  dose of Chemo agent based on patient’s actual height of 163 cm. Thus, the 6^th dose of Adriamycin administered was  excess by 20.82%. It was also urged that during Chemo cycles also, the Patient was suffering from breathlessness, but OP-4 neglected it.  It was stressed that the doctors also failed to do proper cardiac evaluation before starting the Chemo. Even ECHO was not performed during the period of Chemo. It was only the ECG which was taken on 07.09.2001 before the surgery, which was relied upon before Chemo. It was contended that not doing the baseline cardiac evaluation or monitoring cardiac condition during Chemo was against the medical guidelines and protocol, which amounts to deficiency of service and negligence also. The Counsel further submitted that, patient had suffered Chemo induced Cardio-myopathy. It was treated at the Hospital conservatively from 12.7.2002 to 20.7.2002. The doctors at medical oncology department have manipulated LVEF values to 38%.  The Counsel brought our attention to the medical record and the medical literature from the handbook of  Cancer Chemotherapy 5th edition. According to the medical literature Cardiac toxicity occurs due to high dose of Cyclophosphamide and other drugs. The early detection of cardiac dysfunction was important in preventing Cardiomyopathy. It could be done by Conventional methods viz measurement of LVEF, Radionuclide imaging or ECHO during the Chemo. The Counsel further submitted that OP-4 did not take informed consent from the Patient before staring Chemo cycle. The Counsel further submitted that the patient had approached AIIMS for second opinion on 30.8.2008. After examination and several tests  including CT Angiography of heart , it was confirmed by AIIMS that  the Patient suffered Cardiomyopathy due to toxicity of Adriamycin, because of the excess dose.  The pumping power of the Patient’s heart became very poor and the LVEF was critically below the average and she was diagnosed as CHF.  Since 2003, patient started having memory loss and therefore, in October, 2005, MRI scan of brain was performed. It revealed mild diffuse cortical atrophy. The Patient was diagnosed as Mild Cognitive Impairment (Demantia).  

8.       Per Contra, Learned Counsel for the OPs vehemently argued that, the Complaint was barred by limitation. It was filed after considerable delay after the Cause of action had arisen. The Counsel submitted that, the Patient was a high risk one, because of her ER/PR negative status and over expression of HER 2 neu, and for such patient six cycles of Anthracycline were recommended. The Counsel relied upon on an Article published in International Expert Consensus on Primary therapy of early breast cancer, 2005 (Annexure II). Despite poor prognosis, the Patient survived for 10 years, which according to the Counsel, proved the efficacy of Chemo. The Counsel brought to our attention the method for calculation of dosage for Chemo. He submitted that, even if the patient’s height was taken as 173 cm or 163 cm, the dose of Adriamycin will be  99.6 and 97.2 respectively, which was rounded up to 100 mg. Thus, it was not an excess dose as alleged. The Counsel further submitted that, as per internationally accepted protocol, the Adriamycin can be administered up to Cumulative dose of  450 mg/ m² . However, in the instant Patient it would be 450 x 1.62 = 747 mg, whereas the Patient had received 600 mg of Adriamycin in the 6 cycles.  He further submitted that the Anthracycline induced CHF depends upon the Cumulative dosage, there is 5.1.% incidence of CHF if the total dose of Doxoribicin is above 400 mg/m²;  however, the Patient received the dose which was less than 400 mg/m². In the instant case patient was administered only 600 mg of Adriamycin, i.e. 600/1.62= 370 mg/m², therefore there was 0.15% chances of developing CHF.  The counsel brought to our attention to ASCO guidelines (Annexure 8). He submitted that, as per the said guidelines 2D ECHO is needed, when the   Cumulative   dose of drug reaches to 450 mg/m², but in the present case Patient had received only 370mg/m² of Anthracycline. She did not have any symptoms of CHF during the entire course of treatment. However, at the end of Chemo, X-ray chest was performed; it revealed normal size of heart.   The counsel further submitted that, the Patient and her family members were made aware of the adverse effect of Chemo and they had signed the consent form before initiation of the Chemo. 

9.  We have given our thoughtful consideration to the arguments advanced by both the Learned Counsel.  Regarding limitation, as per the material on record, the Complaint filed was not  time barred.  If we see the chronology of events,  that on 16.07.2002 the ECHO revealed low LVEF (24%) and marked Global Hypokinesia of Left Ventricle, OP-6 Dr Pradeep Rustogi made, a provisional diagnosis of myocarditis/cardiomyopathy.   She was admitted in the Hospital and was treated, The repeat Electrocardiogram showed improved LVEF (38) %; she remained asymptomatic and was discharged on 20 July, 2002 with the advice to take prescribed medicines.   She was given Cardace (1.25 mg.), Digoxin (0.25 mg.) half tablet, Cardarome (100 mg), Frusemene (half BD).   Thereafter, the  Patient  got admitted at Moolchand Kharaiti Lal Hospital  from 24.07.2002 to 05.08.2002 , but this fact was never revealed to the Hospital. Though the Complainant did not visit Hospital after 2004, but she was regularly consulting OP-2/Dr. K. K. Pandey and OP-6/Dr. Pradeep Rustagi till the year 2005. and thereafter in August 2008, she had approached   AIIMS, New Delhi for second opinion. It was only when she consulted Delhi Heart and Lung Institute when she came to know about Cardiomyopathy and reduced LVEF @ 36%.  Thus, it was a continuous cause of action.  

10.       The main grouse of the Complainant was that the Chemo was administered to her negligently, which had caused serious and irreparable damage to her heart, lungs and brain;  the treatment was given at the Hospital without taking due  precautions which were absolutely essential. Therefore, non-observance of these precautions coupled with over-dose of Adriamycin resulted in damage to the patient. 11.    There is no gain-saying that the treating doctors are expected to take all necessary precautions during the Chemo like Cardiac monitoring and adjustment of the dose as per the patient’s reducing body weight and condition of the heart, to  avoid/minimize the adverse side effects. In the instant case, it is pertinent to note that the weight of the patient kept on reducing after every cycle. It dropped to  42 kgs from the initial 55 kgs before the last cycle of Chemo, but for the 6^th cycle of Chemo. OP-4 did not advise proportionate reduction in dose of Adriamycin to the patient. In our opinion, it was the combined effect of the wrong height recorded (10 cm in excess) and the 13 kg reduction in the weight of the patient, that the dosage for 6^th cycle was 20.8% excess. Secondly, OP -2 gave Brachy therapy to the patient, which was not contemplated in the treatment plan. The patient or her family members were not informed about such therapy during the course of several discussions of the treatment plan. The medical record of Delhi Heart and Lung Institute, and the second opinion obtained at AIIMS, New Delhi also confirmed the diagnosis of restrictive lungs disease due to radiation fibrosis / radiation induced injury, which was incurable.  

12.       We have perused the Expert opinion given by the medical board constituted by the Dean of Maulana Azad Medical College, New Delhi.  For the sake of ready reference, the relevant extracts are reproduced below;

            Smt. Sheela Srivstava,67 F, was diagnosed cancer right breast (T2NoMo) and underwent conservative surgery for the same on 5/9/2001 (wide local excision and Axillary clearance).  Histopathology confirmed the diagnosis of infiltrating ductal carcinoma with lymphatic invasion.  The tumor was ER, PR(-) ve and over expressed Her 2 Neu.  Post operatively, she received external beam radiotherapy to right breast and superclavicular fossa.  (27.9.2001 to 1.11.2001).  She also received a boost of interstitial brachy therapy (17-11-2011 to 19-11-2001).  Due to unfavorable breast cancer profile (ER, PR (-)ve & Her-2neu over expression), she was recommended adjuvant chemo therapy based on Adriamycin and Cyclophosphamide.  According to the Chemoplan, she received 6 cycles of this therapy which concluded on 21.3.02.

          This therapy is along well accepted lines of treatment for this stage of disease and method of surgery.  We have been provided documentation provided by one party.

          Our findings as per the available records on the information sought from the panel of doctors are:

            1. Evaluation of cardiac status prior to administration of Adriamycin is recommended and advisable.  We are unable to find any record of this evaluation in the documents supplied to us.

          2. The height of the Patient as documented and as claimed by the applicant are at variance.  This requires verification.  The dosage of Adriamycin is calculated based on height and weight and hence body surface area.  Hence inaccuracies in readings will impact on the dosage administered.

          3. Cardiac toxicity of Adriamycin and radiation fibrosis of lungs are well known side effects of Adriamycin and Radiotherapy respectively.  However, they are very effective modalities and the risk benefit ratio is to be considered.

          As per the documents, the Patient is cancer free till date; which indicates the effectiveness of this therapy.

Thus, although the body of experts has not given its final opinion on the question whether there was any deficiency in treatment of the Patient, but its observation to the effect that Cardiac evaluation prior to administration of Adriamycin was necessary and inaccuracies in recording the height and BSA can impact the dosage administered, sufficiently lead to the inescapable conclusion that what ought to have been done by the Doctors in charge of Chemo that had not been done.   

13.     The Complainant/ Patient had not contested the complaint on the diagnosis and method of treatment. Evidently, the Complaint was filed because of the gross negligence in administration of high doses of Adriamycin during Chemo, without proper assessment of  Cardiac condition and body weight of the patient. Therefore,  the patient had suffered  several complications and became debilitated life. We agree with the submission of  Dr. D. C. Doval/OP- 4 that, though the tumor size was small (2 cm.), on the basis of tumour marker studies, it was a high risk Carcinoma breast (T0,N0,M0) and therefore, six cycles of Anthracycline based Chemotherapy were recommended.  Thus, in our view OP-4 had acted in the best interest of the Patient. 

14.     Now, we shall examine whether the dosage was excessive?.

The calculation of dosage is based on height and weight of the patient, i.e. the body surface area (BSA). It is calculated as per following formula :

                                         ______________

                             BSA  =√ Height X Weight    

                                                3600

                             Dosage of medicine = BSA X 60 mg.

Based on the above formulas, in the instant case;                         

1. For 163 cm height,

               _____________

BSA = =√ 163 X 58/3600 = 1.62 m²

               Thus, dose of Adriamycin: 60 X 1.62 = 97.2 mg-  rounded to 100 mg  

                                                      _____________

(b) For 173 cm. height, BSA :√ 173 X 53/3600 = 1.66 m²

 Thus, dose of Adriamycin: 60 X 1.66 = 99.6 mg – rounded to 100 mg

Therefore, on the basis of (a) and (b) the dose calculated was 100 mg only. There was no difference even if the height of the patient recorded as 163 or 173 cms.  As per the literature on internationally accepted protocol,  Adriamycin can be administered up to 450 mg/m² .Therefore, in the instant case, it will be  450 X 1.62 i.e. 747 mg, whereas the Patient had received six cycles of Chemo, thus total was   600 mg(6x100) of Adriamycin.  According to the medical literature, the incidence of  CHF depends upon the cumulative dosage.  In the present case, the Patient was administered only 600 mg of Adriamycin i.e. 370 mg/m² which was within the recommended cumulative dose of 400 mg/m^2. As per medical literature, there is 5.1% incidence of CHF if the total dose of Doxorubicin is above of Dodoribicin 0.14% incidence of CHF is reported.

15.     Next question for our consideration is whether adequate Cardiac Monitoring or the Patient was done before subjecting her to Chemo?

To know about Cardiac effects of Chemo, we have gone through various medical literature filed by both the parties. We also took reference from the books on Cardiology. Upon perusal of entire medical record in the light of these references, it transpires that, one ECG of the Patient was done before mastectomy surgery and another prior to brachytherapy.  OP-4 took cardiology opinion prior to start of Chemo but she was declared fit for Chemo without any fresh ECG or ECHO. In our view the Patient was declared fit for Chemo without proper/adequate evaluation of her heart condition and thus, the Cardiology and Medical Oncology department of the Hospital failed to evaluate patient’s heart condition before starting Chemo, which amounts to lack of care, expected from a medical professional. 

16.     The next question is whether during Chemo cycles, the treating doctors failed to monitor the patient’s Cardiac function?  It is an admitted fact that, OP-4 relied upon the ECG and Cardiology opinion to start with the Chemo cycles. However, OP-4 failed to evaluate LVEF at the time of initiation of Chemo. In this context we have may usefully refer to medical text books and medical literature from few articles on cardiac monitoring during Chemotherapy;

• Monitoring cardiac function in patients receiving Doxorubicin- Semin Nucl Med 2005 Jul;35(3):197-201, Lu Ping

• < > Vol. 7, N° 11 - 25 Nov 2008,Prof. Leopoldo Perez de Isla , An article from the E-Journal of the ESC Council for Cardiology Practice  

   

   

   

  • Chemotherapy-induced Cardiotoxicity. Mædica. 2013;8(1):59-67,Florescu M et al

   

  We have noted the following information from medical literature as;

  • Cardiac Function:

    Cardiotoxicity is a known risk of anthracycline treatment. Anthracycline-induced cardiotoxicity may be manifested by early (or acute) or late (delayed) events. Early cardiotoxity of Doxorubicin consists mainly of sinus tachycardia and/or electrocardiogram (ECG) abnormalities such as non-specific ST-T wave changes. Tachy-arrhythmias, including premature ventricular contractions and ventricular tachycardia, bradycardia, as well as atrioventricular and bundle-branch block have also been reported. These effects do not usually predict subsequent development of delayed cardiotoxicity, are rarely of clinical importance, and are generally not considered an indication for the suspension of doxorubicin treatment.

    Delayed cardiotoxicity usually develops late in the course of therapy with Doxorubicin or within 2 to 3 months after treatment termination, but later events, several months to years after completion of treatment, have also been reported. Delayed cardiomyopathy is manifested by a reduction in LVEF and/or signs and symptoms of congestive heart failure (CHF) such as tachycardia, dyspnoea, pulmonary edema, dependent edema, cardiomegaly and hepatomegaly, oliguria, ascites, pleural effusion, and gallop rhythm. Subacute effects such as pericarditis/myocarditis have also been reported. Life-threatening CHF is the most severe form of anthracycline induced cardiomyopathy and represents the cumulative dose-limiting toxicity of the drug.

    In one of the research study, the probability of developing impaired myocardial function, based on a combined index of signs, symptoms and decline in left ventricular ejection fraction (LVEF) is estimated to be 1 to 2% at a total cumulative dose of 300 mg/m² of doxorubicin, 3 to 5% at a dose of 400 mg/m², 5 to 8% at a dose of 450 mg/m² and 6 to 20% at a dose of 500 mg/m² given in a schedule of a bolus injection once every 3 weeks. In a retrospective review, the probability of developing congestive heart failure was reported to be 5/168 (3%) at a cumulative dose of 430 mg/m² of doxorubicin, 8/110 (7%) at 575 mg/m² and 3/14 (21%) at 728 mg/m². In a prospective study of doxorubicin in combination with cyclophosphamide, fluorouracil and/or vincristine in patients with breast cancer or small cell lung cancer, the probability of CHF at various cumulative doses of doxorubicin was 1.5% at 300 mg/m², 4.9% at 400 mg/m², 7.7% at 450 mg/m² and 20.5% at 500 mg/m². The risk of developing CHF increases rapidly with increasing total cumulative doses of doxorubicin in excess of 400 mg/m².

  Cardiotoxicity may occur at lower doses in patients with prior mediastinal / pericardial irradiation.

  • Monitoring Cardiac Function:

  Myocardial toxicity manifested in its most severe form by potentially fatal congestive heart failure may occur either during therapy or months to years after termination of therapy.

  The risk of serious cardiac impairment may be decreased through regular monitoring of LVEF during the course of treatment with prompt discontinuation of Doxorubicin at the first sign of impaired function. The preferred method for assessment of cardiac function is evaluation of LVEF measured by multi-gated radionuclide angiography (MUGA) or echocardiography (ECHO). An ECG may also be done. A baseline cardiac evaluation with a MUGA scan or an ECHO is recommended, especially in patients with risk factors for increased cardiac toxicity. Repeated MUGA or ECHO determinations of LVEF should be performed, particularly with higher, cumulative anthracycline doses. The technique used for assessment should be consistent through follow-up. In patients with risk factors, particularly prior anthracycline or anthracenedione use, the monitoring of cardiac function must be particularly strict and the risk-benefit of continuing treatment with doxorubicin in patients with impaired cardiac function must be carefully evaluated.

  Endomyocardial biopsy is recognized as the most sensitive diagnostic tool to detect anthracycline-induced cardiomyopathy; however, this invasive examination is not practically performed on a routine basis. ECG changes such as dysrhythmias, a reduction of the QRS voltage, or a prolongation beyond normal limits of the systolic time interval may be indicative of anthracycline-induced cardiomyopathy, but ECG is not a sensitive or specific method for following anthracycline-related cardiotoxicity.

   In adults, a 10% decline in LVEF to below the lower limit of normal or an absolute LVEF of 45%, or a 20% decline in LVEF at any level is indicative of deterioration in cardiac function.

  Patients under chemotherapy treatment have an increased risk of developing cardiac toxicity.  The Cardiotoxicity associated with doxorubicin and trastuzumab is a well-known obstacle in the treatment of breast cancer patients. The doxorubicin cardiotoxicity is con­sidered to be irreversible, so the early detection of left ventricular (LV) dysfunction and prevention of overt heart failure is important. There are number of trials that have sug­gested that early decline of LV ejection fraction (LVEF) after doxorubicin chemotherapy is associated with long term de­velopment of cardiac dysfunction. The early detection of cardiotoxicity and proper management, even in asymptomatic patients, is considered critical .Guidelines for cardiac func­tion monitoring of doxorubicin cardiotoxicity have been rec­ommended , but these guidelines are not strictly followed in clinical practice.  In patients aging <15 years or >60 years, cardiac func­tion monitoring after administration of relatively low cumula­tive dose of doxorubicin is recommended. However, in considering that the early decline of LVEF is as­sociated with development of the subsequent cardiomyopathy   and the early treatment of cardiotoxicity can lead to re­covery of LVEF, thus early detection is essential. Estimat­ing the underlying cardiovascular risk factors, detecting tem­porary events, and identifying subclinical changes may be helpful in the early detection and prediction of subsequent cardiomyopathy. Therefore periodic clinical evaluation by ECHO assessment particularly is the cornerstones of the measurement of cardiac dysfunctions. Thus, measurements of LVEF should be performed with using the same method during the complete follow-up.  The cardiac failure symptoms are often non-specific therefore assessment of cardiac function is of critical importance in such patients. A clinical examination, EKG and echocardiography is always recommended before each cycle and every 4 – 12 weeks after the cycle and during the complete treatment.  

  Therefore, in our considered view, a careful monitoring to identify whether the patient was at risk of developing unpredictable and sometimes-irreversible cardiac dysfunction was crucial. Serial measurement of LVEF remains a useful and widely adopted modality in monitoring patients that are receiving doxorubicin. In the instant case, it is evident from the medical record that, the doctors in Cardiology and the treating doctors failed to monitor the patient during Chemo.

  17.     The next question falling for our consideration is whether at the 6^th cycle of Chemo Opposite Parties had failed to determine proper dose of Adriamycin?

  It should be borne in mind that, during cancer treatment a patient does suffer nausea, loss of appetite, burns and other complications. In the instant case at the 6^th Cycle of Chemo patient’s weight fell from 55 kg to 42 kg. However, the dose of 100 mg Adriamycin was maintained throughout. If we take weight at 42 kg and height 163 cm, then BSA will be 1.2 and the dose of Adriamycin will be 1.2x 60= 72 mg/m². In any event, even if we calculate by taking height as 173 cm, the BSA will be 1.3 and the dose of Adriamycin will be 1.3x 60=72 mg/ m².  In the instant case, the Patient was given 100 mg/m². Thus, the dose of Adriamycin was 20-30% excess, which amounts to deficiency in service on the part of OP-4.

   18. The next point for consideration is whether a proper valid consent was taken from the Complainant?

  We are rather surprised to see the Consent form,  the relevant text from the consent form is reproduced as below:

  High Risk Informed Consent for Chemotherapy.

            “………xxx….

  ………xxx …

   

   The patient being a child is liable to suffer certain side effects of chemotherapy like stunting of physical and mental growth; loss of reproductive capacity in later life as a result of damage to Testes/Ovaries, ear, kidney, heart and lung problems in later life.  The treating doctors have given no guarantee in terms of cure and we fully understand that the disease may progress despite treatment…………..”

   

  In our view it was not an informed consent as understood in the legal parlance.  Besides being vague it was not signed by the Patient herself, who at the relevant time was in a fit state of mind to understand it and sign it, but it was got signed by her son.  Being conscious and coherent, the consent should have been obtained from her. In our opinion, therefore, a valid consent was not obtained from the Patient.

  19.     Regarding the question of informed consent, we draw support from the decisions of the Hon’ble Supreme Court. In Samira Kohli vs. Dr. Prabha Manchanda and Anr. (2008) 2 SCC 1, Hon’ble Supreme Court has  summarized the principles of consent in para 4,  which is reproduced  below:

             “49.   we may now summarise principles relating to consent as follows:

  1. A doctor has to seek and secure the consent of the patient before commencing a “treatment” (the term “treatment” includes surgery also).The consent so obtained should be real and valid, which means that : the patient should have the capacity and competence to consent; his consent should be voluntary; and his consent should be on the basis of adequate information concerning the nature of the treatment procedure, so thathe knows what he is consenting to.”

          

                     The court also observed in para 23 as:

   

  23. It is quite possible that if the patient been conscious, and informed about the need for the additional procedure, the patient might have agreed to it. It may be that the additional procedure is beneficial and in the interests of the patient. It may be that postponement of the additional procedure (say removal of an organ) may require another surgery, whereas removal of the affected organ during the initial diagnostic or exploratory surgery would save the patient from the pain and cost of a second operation. Howsoever practical or convenient the reasons may be, they are not relevant. What is relevant and of importance is the inviolable nature of the patient's right in regard to his body and his right to decide whether he should undergo the particular treatment or surgery or not. Therefore at the risk of repetition, we may add that unless the unauthorized additional or further procedure is necessary in order to save the life or preserve the health of the patient and it would be unreasonable (as contrasted from being merely inconvenient) to delay the further procedure until the patient regains consciousness and takes a decision, a doctor cannot perform such procedure without the consent of the patient.

   

   

  20.     Based on the discussion above, we find that there was deficiency in service on the part of the Hospital and the treating doctors during the post-surgical treatment of the Patient.  The Chemo was started without adequate Cardiac assessment and during Chemo, dose of Adriamycin was not correctly determined  and monitored based on the Patient’s height and weight on account of the latter lapse  the Patient had received 20% excess dose during 6^th cycle of Chemo, adversely affecting her heart, leading to serious problems like acute Cardiomyopathy drastically reducing LVEF and ultimately her death. In our considered view, these were the toxic effects of Adriamycin, which could have been prevented, if cardiac evaluation prior to initiation of Chemo was performed.  Therefore,  in our opinion the Hospital and the treating doctors failed in their duty of care on several counts. 

   

   

  21.   In view of the aforegoing discussion, we are in complete agreement with the State Commission that there was deficiency in service on the part of the Hospital and the Doctors in giving Chemotherapy to the Patient. In so far as the role of Opposite party No.2, Dr. K. K. Pandey who had performed Mastectomy of the patient and his associate Dr.Rajiv Kumar (OP-5) Surgical Oncologist   had no role in the Chemo or Radiotherapy. Also, Dr.S.Hukku had only administered Radiotherapy and    his role was limited to radiotherapy. Therefore, we do not find any negligence on the part of Dr.K.K.Pandey, Dr.S.Hukku and Dr.Rajiv Kumar. Accordingly we exonerate Opposite Parties 2, 3 and 5. Accordingly, the Appeal preferred by Opposite Parties is partly allowed to the extent indicated above, and hold that OP No. 2, 3 and 5 were not negligent in treating the Patient.  

  22.   We may now take up the Appeal preferred by the Complainants, praying for enhancement of the compensation awarded by the State Commission. The Hon’ble Supreme Court in V. Krishnakumar Vs. State of Tamil Nadu & Ors., (2015) 9 SCC 388 while quantifying the compensation has sagely relied on restitution in integrum. This principle has been recognized and relied on in Malay Kumar Ganguly Vs. Sukumar Mukherjee (2009) 9 SCC 221 and in Balram Prasad Vs. Kunal Saha & Ors (2014) 1 SCC 384 in the following passage from the later:-

  “170. Indisputably, grant of compensation involving an accident is within the realm of law of torts.  It is based on the principle of restituio in integrum. The said principle provides that a person entitled to damages should, as nearly as possible, get that sum of money which would put him in the same position as he would have been if he had not sustained the wrong. (See: Livingstone Vs. Rawyards Coal Co.)”

  23.     This principle postulates that the aggrieved person should get that sum of money, which would put him in the same position if he had not sustained the wrong.  It must necessarily result in compensating the aggrieved person for the financial loss suffered due to the event, the pain and suffering undergone and the liability that he/she would have to incur due to the disability caused by the event.

  24.     In the instant case, though the sources of income of the Complainant (the deceased) had not been proved but having regard to the fact that, at the time of her admission in the hospital, she was aged about 65 years with traditional background and belonged to a reputed family of  U.P., due to the negligence of OPs No 1,3 to 6, the patient grievous  permanent damage to her heart, bone and brain crippling her to lead her life under physical and mental strain, which again was shortlived as she expired within a few years of Chemo.  There was loss of earning to her husband for quitting his job from J. K. Tyres, and to attend to her .Therefore, we find it to be a fit case for enhancement of compensation as awarded by the State Commission by a further sum of ₹10,00,000/- which would include compensation for mental agony and pain suffered, the loss of consortium and love and affection of the family involved.

  25.     The doctrine of vicarious liability extends to the primary liability of the hospital for the wrongs or negligent acts of its servants, irrespective of whether their employment is permanent or temporary or casual paid or honorary, whole time or part time as in the case of visiting physicians or surgeons.  By now it is well settled that the hospital is also vicariously liable for the acts of its doctors.  (See: Savita Garg Vs. Director, National Heart Institute  (2004) 8 SCC 56 and Balram Prasad [supra]  Following the principles laid down in these pronouncements, we hold that both the Hospital and the Opposite Parties No. 4 and  6 shall be liable for the act of negligence.  Accordingly, we direct that, out of the total compensation of ₹20,00,000/-, the Hospital shall be liable to pay a sum of ₹16,00,000/- and the balance amount of ₹4,00,000/- shall be payable by Opposite Party No. 4 and 6 in equal proportion, i.e. ₹2,00,000/- each.  We may note that, vide order dated 06.02.2015 the Complainants were permitted to withdraw a sum of ₹2,50,000/-, out of the total amount directed to be deposited by the Opposite Parties. The Hospital has deposited the total decretal amount, out of which a sum of ₹2,50,000/- has been withdrawn by the Complainants. The remaining amount lying deposited in this Commission along with interest accrued, if any, shall be released to the patient’s husband forthwith. The balance amount due to the Complainants, in terms of this order shall be remitted by the Hospital and Opposite Parties No. 4 and 6, by means of demand drafts, in favour of Sh. Ravindra Nath Srivastava, husband of the Patient, within four weeks of receipt of a copy of this order, failing which it shall carry interest @ 9% p.a. from the date of filing of the complaint till realization.  Statutory amount deposited at the time of filing Appeal No. 1084 of 2014 shall stand transferred to the Consumer Welfare Fund.

  26.     In the result both the Appeals are partly allowed, leaving the parties to bear their own costs.