DISTRICT CONSUMER DISPUTES REDRESSAL FORUM-II
U.T. CHANDIGARH
Complaint Case No.: 593 of 2007
Date of Inst:24.07.2007
Date of Decision:31.12.2009
Smt.Inderjit Arora wife of Shri J.S.Arora resident of 6183, Modern Housing Complex, Manimajra, Chandigarh.
..…Complainant
V E R S U S
1. Inscol Multi-Speciality Hospital, Sector 34-A, Chandigarh through its Managing Director Sh.Daljit Singh Gujral.
2. Mr.Daljit Singh Gujral, Managing Director, Inscol Multi-Speciality Hospital, Sector 34-A, Chandigarh.
3. Dr.Jayant Banerjee, Medical Superintendent, Inscol Multi-Speciality Hospital, Sector 34-A, Chandigarh.
4. P.S.Mann, Inscol Multi-Speciality Hospital, Sector 34-A, Chandigarh.
5. Mrs.Alveena Samson, Assistant Nursing, Superintending, Inscol Multi-Speciality Hospital, Sector 34-A, Chandigarh.
6. United India Insurance Co., SCO No.123-124, Sector 17-B, Chandigarh through its Manager.
—Opposite Parties
QUORUM SHRI LAKSHMAN SHARMA PRESIDENT
SHRI ASHOK RAJ BHANDARI MEMBER
ARGUED BY: Sh.Gaurav Chopra, Adv. for complainant
Sh.Jai Shree Thakur, Advocate for OPs No.1, 2 and 4
Sh.Rajiv Raina, Adv. for OP-3.
OP No.5 exparte.
Sh.Nitin Grover, Adv. for OP-6.
—
PER LAKSHMAN SHARMA, PRESIDENT
Smt.Inderjit Arora has filed this complaint under section 12 of the Consumer Protection Act, 1986 praying for a compensation of Rs.20 lacs for mental and physical harassment caused to her due to the negligence on the part of OPs in her treatment.
2. In brief the case of the complainant is that she was patient of diabetes for the last 10 years prior to her admission in Inscol Multi-Specialty Hospital (OP-1). She had been under medical supervision of Dr.Jayant Banerjee (OP-3). On 01.08.2005, she started shivering and felt mild fever. She also experienced pain in her left leg. At about 4.00 p.m., she visited the clinic of Dr.Jayant Banerjee (OP-3) who carried out some preliminary tests and thereafter advised her to visit Prime Diagnostic Centre for check up and procedural tests. Therefore, the complainant along with her son went to the above said Prime Diagnostic Centre where High Resolution Harmonic Eco Cardiography was performed on her. (The copy of the report is Annexure C-1.) Dr.U.P.Singh who conducted the above Harmonic Eco Cardiography again referred back the complainant to OP-3 for further management. After perusing the report of Harmonic Eco Cardiography, OP-3 advised the complainant to get her checked up from Dr.Sudhir Saxena. So the complainant went to the clinic of Dr.Sudhir Saxena who checked her and gave some medicines to her. Dr.Sudhir Saxena advised immediate hospitalization and also advised certain investigations such as D-Dimer Test, repeat Eco Test and Sprial CT Chest Scan etc. Dr.Sudhir Saxena again sent the complainant for further management of his treatment to OP-3. So the complainant at the advice of OP-3, got herself admitted in OP-1-Hospital in the evening of 01.08.05 itself. It has further been pleaded by the complainant that she was admitted in Intensive Care Unit (ICU) where Ultra Sound Test, Doppler Test were carried out. However, none of the tests as advised by Dr.Sudhir Saxena were carried out in order to ascertain conclusively that the complainant was suffering from Pulmonary Embolism. During the night, the condition of the complainant started deteriorating. It was recommended that injection namely TPA {(Tissue Plasmogim Activator(Actilyse)} be administered to the complainant. So the said TPA injection was procured from M/s Kapoor & Company, Sector 38-D, Chandigarh for a sum of Rs.72000/-.
According to the complainant, as per the TPA Instruction Manual as well as Consumer Medicine Information, the said injection was to be administered only after confirmation of Pulmonary Embolism disease and by a well qualified physician experienced in the use of thrombolytic treatment and at a place having the facilities to monitor its use as there are dangerous side effects of the said injection which may need immediate care and treatment. According to the complainant, despite the aforesaid instructions, the said injection was administered without confirming that the complainant was suffering from pulmonary embolism and by a person who was not having the requisite qualification and was not even competent to administer the said injection. It has further been pleaded that at the time of administration of the injection, even certain basic facilities such as ventilator etc. were not made available to the complainant when need actually arose for the same. It has further been averred by the complainant that on 02.08.2005 after administration of the injection, the condition of the complainant further deteriorated and no ventilator was made available to the complainant by OP-1. Resultantly, the complainant was moved to Fortis Hospital, Mohali where she remained admitted upto 12.09.2005 i.e. for more than a month or so. Complainant had to spend a lot of money on her further treatment in Fortis Hospital, Mohali. After her discharge from the Fortis Hospital, Mohali on 12.09.2005, her condition again deteriorated, so she got herself again admitted in the Fortis Hospital, Mohali and remained admitted therein from 14.09.2005 to 22.09.2005. Thus, the complainant spent a total sum of Rs.8 lacs on her treatment and this amount had to be spent only because of the negligence on the part of OPs.
It has been averred in the complaint that as per the record maintained by OP-1 her blood pressure remained fluctuating between 110/80 to 120/80 during the whole of the night of 02.08.05. But her blood pressure fell down soon after the administration of the said TPA injection due to the side effect of the injection. The injection was required to be administrated by a qualified physician experienced in the use of thrombolytic treatment and at a place having the facilities to monitor as there are dangerous side effects of this injection which need immediate care and treatment. But no physician with required experience and qualifications, in the use of thrombolytic treatment was present at the time of administration of the injection and the said injection was given by a person who was not competent to administer the said injection. At the time of administration of the injection, resuscitation equipment and appropriate medication was required to be kept available at all the times. However, according to the complainant, when the need of ventilator arose, no ventilator was available. Resultantly, the complainant was discharged from the hospital (OP-1) in a pitiable condition. According to the complainant, OPs had been negligent while administering the TPA injection to her and failed to follow the medical norms for administration of the said injection, which amounts to deficiency in service. In these circumstances, the present complaint was filed seeking the reliefs mentioned above.
3. In the written statement filed by OPs No.1 and 2, it has been admitted that the complainant was admitted in Inscol Multi-Speciality Hospital in the evening of 01.08.2005 and was discharged on 02.08.05. The case of OPs is that after admission of the complainant, certain tests like Ultra Sound Test, Doppler Test were carried out. Both these tests confirmed the Pulmonary Embolism. So other tests recommended by Dr.Sudhir Saxena were not found necessary. Further more, according to Ops, the complainant was not in a fit condition to be taken for further tests as a number of drips had been given to her. It has been pleaded that the blood pressure of the complainant remained fluctuating throughout the period of her admission in the OP-1-Hospital. After confirmation of Pulmonary Embolism, the required medicines as per the advice of Dr.Jayant Banerjee (OP-3) were given to the complainant. The patient was never ignored and was given requisite medical care. Finding that the blood pressure of the complainant was steeply falling requisite medicines were administered as per the advice of Dr.Jayant Banerjee (OP-3). It has further been pleaded that when the condition of the complainant started deteriorating it became necessary to administer TPA injection. So the complainant and her relatives were informed about the possible side effects of the said injection. It has been asserted that the said injection was administered as per the advice of Dr.Sudhir Saxena and he advised the administration of the said injection. All precautions required for administration of the injection were followed. So according to Ops, there was no negligence on the part of Ops in administration of the said injection. It has been asserted that Dr.P.S.Mann who was present at the time of administration of the injection is a duly qualified doctor and he acted as per the instructions of Dr.Sudhir Saxena. It has been asserted that ventilators were available in the hospital. However, when the need arose, in the case of the complainant, the same were already in use by some other patients. This fact was brought to the notice of the complainant and her attendants so that alternative arrangement can be made. The relatives of the complainant arranged a ventilator in the Fortis Hospital, Mohali. So the complainant was discharged for being taken to the Fortis Hospital, Mohali as per the request of the complainant’s relatives and attendants. In these circumstances, according to Ops No.1 and 2, there is no deficiency in service on its part and the complaint qua them deserves dismissal.
4. In its separate written statement, OP-3 pleaded that on 01.08.05, the complainant visited his clinic complaining fever, sweating and breathlessness. She had also infection on her left shin. It has further been pleaded that complainant told him that she had been taking some medicines including antibiotics on her own for many days prior to her visit to his clinic. According to OP-3, he conducted ECG which showed right bundle branch block. It clearly suggested Pulmonary Embolism from the deep vein in her infected left leg. She was advised to get echo cardiogram. The report of echo cardiogram suggested that the complainant had pulmonary hyper tension with normal right ventricular size, suggesting an embolism. So OP-3 advised the complainant to immediately contact Dr.Sudhir Saxena who was a cardiologist at Inscol Hospital. Thereafter, the complainant went to Dr.Saxena who suspected that the complainant was suffering from Pulmonary Embolism and advised the complainant to get herself admitted in the hospital immediately. She was also advised some tests for confirmation of the said disease. As per advice given by Dr.Sudhir Saxena, the complainant got herself admitted in OP-Hospital where she was put on molecular weight heparin therapy and an ultrasound, Doppler and D-Dimer tests were conducted. The complainant was treated with antibiotics for infection, insulin for high blood sugar and oxygen for low saturation and along with 1/V fluids were started. However, due to some medical reasons, the BP of the patient started dropping due to which inotropes were started. It has further been pleaded that OP-3 is a consultant but had no absolute control over the patient’s serious condition who was being treated in Inscol Hospital. The injection was administered in the presence of Dr.Sudhir Saxena and the relatives of the complainant were informed about the side effects of the said injection before administration. It was only after the suggestion of Dr.Saxena that he would put an IVC filter if injection will not work and C.T. angiography was not possible as the patient could not be shifted, that the injection was administered by the well qualified staff of OP-1 on the instructions of Dr.Saxena (A qualified Cardiologist). As the complainant’s B.P. and oxygen level continued to fall so CVP line was put and when CVP was found to be high as per the records. Need of ventilator was felt by Dr.Ashutosh Sharma. But at that time, all ventilators were occupied and therefore, the complainant was given option of shifting to another hospital. It has been pleaded that it is only with the express consent of the complainant’s son that the complainant was shifted to Fortis Hospital.
According to OP-3, he is doctor of great repute and practiced as a diabetologist in Chandigarh. He passed his MBBS from Christian Medical College, Ludhiana and has done his masters in internal Medicine from CMC, Ludhiana. He is diplomat of National board and has done his FCCS from Society of Critical Care Medicine from USA. He has done the course in Diabetologist from University of New Castle, Australia where he was trained to do EEGs, nerve and muscle studies and since then he is doing active practice at Inscol Tertiary Care Hospital. It has further been pleaded that no amount was charged from the complainant by OP-3 and the amount, if any, is charged by OP-1. It is further submitted that the committee constituted by the Punjab Medical Council consisting of well qualified professionals and experts exonerated OP-3. In these circumstances, according to OP-3, there is no deficiency in service on his part and the complaint qua him also deserves dismissal.
5. OP-4 adopted the written statement filed on behalf of Ops No.1 and 2. It has been pleaded by OP-4 that D-Dimmer Test was carried out before administering TPA and the treatment was given as per the directions of the treating doctors. It has further been pleaded that he (OP-4) possesses the recognized medical qualifications. According to this OP, there is no deficiency in service on his part and therefore, the complaint qua him deserves dismissal.
6. OP-5 was duly served but nobody appeared on her behalf to contest the case. Therefore, OP-5 was ordered to be proceeded against exparte vide order dated 11.10.2007.
7. In its separate written statement, OP-6 i.e. United Insurance Company pleaded that only OP-3 i.e. Dr.Jayant Banerjee who obtained the insurance policy was insured under insurance policy No.082401/46/04/01576 for the period from 05.03.05 to 04.03.06. It has further been pleaded that the complainant was an old patient of hyper tension and diabetes. In the year 2005 after giving first aid, the complainant was advised to consult a cardiologist. No treatment was given by OP-3 to the complainant and thus no medical negligence can be attributed to OP-3 who is insured with insurance company. In these circumstances, according to OP-6, there is no negligence on the part of OP-3 and hence, the complaint qua it deserves dismissal and OP-6 is not liable to indemnify the OPs (except OP-3) who are not insured with it.
8. We have heard the learned counsel for the parties and have perused the record and Annexures placed on record by the parties and the written arguments filed on behalf of the complainant as well as OPs No.1 to 4 very carefully.
9. It has been argued vehemently by the learned counsel for the complainant that due to negligence and deficiency in service on the part of OPs in providing proper treatment to the complainant, she had to be shifted to Fortis Hospital, Mohali for treatment. She spent a sum of Rs.8 lacs. In addition to it, she also suffered mental as well as physical agony. Therefore, according to the complainant, the complainant is entitled to the refund of the amount paid by her towards her treatment in the Fortis Hospital, Mohali and also for compensation for physical and mental agony.
10. The deficiencies in service pointed by the learned counsel for the complainant are as under:-
i) No diagnosis was carried out for confirming pulmonary embolism, which would have warranted the administration of the injection TPA in case Pulmonary Embolism was confirmed.
ii) Injection TPA was neither given by a qualified physician nor a specialist nor given under the supervision of a qualified physician experienced in the use of thrombolytic treatment.
iii) Lack of Post Operative procedure and equipment.
11. Now the question arises whether the TPA was administered without confirmation of Pulmonary Embolism and whether it was necessary for the OPs to confirm the Pulmonary Embolism before administering the TPA.
12. Annexure C-11 is the literature regarding administration of TPA. Under the heading “what actilyse is used for”, it has been mentioned as under:-
“Actilyse is intended to be used either during the early stages of a heart attack or in a condition of the lungs known as acute massive Pulmonary Embolism Actilyse is also used in the early treatment (within 3 hours of onset of symptoms) of a particular type of stroke known as Actute Ischaemic Stroke. Actute Ischaemic Stroke occurs when a blood clot blocks a blood vessel in the brain. This leads to a sudden interruption of blood flow to an area of the brain and results in damage of brain tissue
Actilyse works by dissolving clots in the blood vessels. These clots cause disease by interfering within normal blood flow”.
From the bare reading of above, it is apparent that TPA has to be administered in case of acute massive Pulmonary Embolism. So before administration of the TPA, it is necessary to confirm that patient to whom the TPA is administered is suffering from acute massive Pulmonary Embolism.
13. In the present case, admittedly on 01.08.2005, the complainant started shivering and felt mild fever. She also felt pain in her left leg. So the complainant approached Dr.Jayant Banerjee (OP-3) who clinically examined her and advised tests and procedural checks from Prime Diagnostic Centre and Heart Institute, Chandigarh where High Resolution Harmonic Eco Cardiography was performed upon her. From the above said test report, it was revealed that pulmonary artery was dilated. The report is Ex.C-1. Dr.U.P.Singh who conducted the above said test again referred back the complainant to Dr.Jayant Banerjee (OP-3) for further management. After going through the report, Dr.Jayant Banerjee (OP-3) suspected that the complainant was suffering from Pulmonary Embolism so he referred her to Dr.Sudhir Saxena who examined the complainant and also suspected that she was suffering from moderate pulmonary hyper tension. He advised immediate hospitalization of the complainant. For confirmation of the disease, he advised the following tests:-
a) D-Dimer Test
b) To Repeat Echo Test.
c) Spiral CT Chest.
Dr.Sudhir Saxena further sent back the complainant to Dr.Jayant Banerjee (OP-3) for further management. Thereafter, admittedly as per the advice of Dr.Saxena and Dr.Banerjee, the complainant got herself admitted in the OP-Hospital. She was admitted in ICU where according to the complainant, none of the tests as advised by Dr.Sudhir Saxena in his prescription slip (Annexure C-2) were carried out.
14. On the other hand, the case of the OPs is that after admission of the complainant, Doppler test, D-Dimer test, ultrasound abdomen were conducted. It has further been pleaded that Dr.Banerjee and Dr.Saxena had also found that the complainant was suffering from Pulmonary Embolism on the basis of the clinical tests and report of the Prime Diagnostic Centre and Heart Institute. In these circumstances, according to OPs, there was sufficient material to confirm the said disease and thus there is no deficiency in service on this score.
15. It is pertinent to mention here that there is dispute between the parties on the question as to whether D-Dimer Test was conducted or not. The case of the OPs is that the blood sample of the complainant was sent to Fortis Hospital for D-Dimer Test where D-Dimer Test was conducted and the report of the D-Dimer Test is Annexure R-1/B. The above said report has been seriously disputed by the complainant and it has been argued that the above said report is a fabricated document and in fact no D-Dimer Test was conducted in Fortis Hospital on 01.08.2005. Our attention has been drawn to the letter (Annexure C-32) written by the Fortis Hospital to the counsel for the complainant clarifying therein that only one D-Dimer Test of the complainant was conducted in the Fortis Hospital and the said test was conducted on 07.08.2005, the report of which is Annexure C-16. The complainant also sought information from the Punjab Medical Council under the Right to Information Act, 2005 vide letter (Annexure C-44). Vide letter (Annexure C-44), the complainant was informed that the report dated 01.08.2005 regarding D-Dimer Test is not on the record of the Punjab Medical Council (It is pertinent to mention here that the complainant had earlier filed complaint (Annexure C-38) before the Punjab Medical Council alleging the misconduct on the part of the doctors of OP-Hospital and in that case certain documents were placed on record by both the parties. Our attention has also been drawn to the invoice (Annexure C-9) issued by the OPs regarding different charges recovered from the complainant for carrying out various tests as well as towards the treatment and hospitalization of the complainant. As per this invoice, the complainant has not been charged for D-Dimer Test.
16. It is pertinent to mention here that the OPs have not placed on record any documentary evidence to show that the blood was sent to Fortis Hospital or that the blood was received in the Fortis Hospital on 01.08.2005. Nor is there any documentary evidence to prove that the said blood was tested by the Fortis Hospital on that day. Even the affidavit of the person who took the blood sample to the Fortis Hospital and that of the person who received the blood sample in the Fortis Hospital have not been placed on record. In these circumstances, no reliance can be placed on report (Annexure R-1/B) particularly in view of the letter (Annexure C-32) issued by the Fortis Hospital clarifying that only one D-Dimer Test of the complainant was conducted in the Fortis Hospital on 07.08.2005 and the report thereof is Annexure C-16. Even the complainant has not been charged for carrying out the D-Dimer test as is evident from the invoice (Annexure C-9). Had D-Dimer test been conducted earlier, OP-1 would have certainly charged for it, particularly if it had paid for it to the Fortis Hospital. So to our mind from the evidence on record, it is not proved that D-Dimer Test of the complainant was conducted on 01.08.2005 and that the report Annexure R-1/B pertains to that test.
17. It has further been argued by the learned counsel for the OPs that C.T.Scan and other tests as advised by Dr.Sudhir Saxena could not be conducted because of unstable condition of the complainant. This argument of the learned counsel for OPs is also without any force. From the record of ICU (Annexure C-8), it is apparent that blood pressure of the complainant varied from 100 to 80 from 8.00 p.m. to 3.00 a.m. and the complainant also remained stable during the night. The complainant was also taken for ultra sound test. The above facts show that the condition of the complainant remained stable upto 3.00 a.m. from the time of her admission. So the OPs had sufficient time to get the required tests conducted upon the complainant. In these circumstances, the plea of OPs that the tests could not be conducted because of the unstable condition of the complainant has no force.
18. Admittedly the other tests i.e. CT Scan and repeat of High Resolution Harmonic Eco Cardiography as advised by Dr.Sudhir Saxena were also not carried out.
The case of the OPs is that Dr.Banerjee in his observations (Annexure C-6) had only suspected Pulmonary Embolism. He noted the possibility of coronary artery disease (CAD), Cellulites/DVt Vein Thrombosis. Therefore, the complainant was sent to Prime Diagnostic Centre and Heart Institute for High Resolution Harmonic Eco Cardiography test. It is further the case of OPs that Dr.Sudhir Saxena also suspected DVT, Pulmonary Thrombosis Embolism and Pulmonary Hypertension. Thus, according to OPs, Dr.Banerjee and Dr.Saxena came to the conclusion that the complainant was, in all probabilities, suffering from acute Pulmonary Embolism. Therefore, OPs conducted ultrasound and ECG of the complainant which confirmed Pulmonary Embolism. In these circumstances, according to OPs, the diagnosis of Pulmonary Embolism was duly confirmed.
19. To our mind the stand taken by OPs is contrary to the material on record. Annexure C-3 is the report of ultrasound. From the said report, it is apparent that no positive sign of Pulmonary Embolism was found and the said report is normal. In these circumstances, the stand taken by OPs is contrary to the report placed on record by the complainant. Otherwise also the stand taken by OPs is also contrary to the standard method of diagnosis as mentioned in Wikipedia on Pulmonary Embolism. In the above said medical literature, the Pulmonary Embolism has been defined as under:-
“Pulmonary Embolism (PE) is a blockage of the pulmonary artery or one of its branches, usually occurring when a deep vein thrombus (blood clot from a vein) becomes dislodged from its site of formation and travels or embolizes to the arterial blood supply of one of the lungs. This process is termed thromboembolism.”.
Under the head “Combining Tests” into algorithms, it has been mentioned as under:
“Recent recommendations for a diagnostic algorithm have been published by the PIOPED investigators, however, these recommendations do not reflect research using 64 slice MDCT. These investigations recommended:-
· Low clinical probability. If negative D-dimer, PE is excluded. If positive D-dimer, obtain MDCT and based treatment on results.
· Moderate clinical probability. If negative D-dimer, PE is excluded. However, the authors were not concerned that a negative MDCT with negative D-dimer in this setting has an 5% probability of being false. Presumably, the 5% error rate will fall as 64 since MDCT is more commonly used. If positive D-dimer, obtain MDCT and based treatment on results.
· High clinical probability. Proceed to MDCT. If positive, treat, if negative, additional tests are need to exclude PE”.
20. In another book i.e. Braunwald’s Heart Disease, a text book of Cardiovascular Medicine, 7th Edition under the heading ‘Overall Strategy : An integrated Diagnostic Approach”, it has been mentioned as under:
Overall Strategy : An Integrated Diagnostic Approach:-
A wide array of diagnostic tests is available for investigation of suspected PE.
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To screen for PE in the Emergency Department, we obtained a rapid turn around plasma D-dimer ELISA. If normal, then PE is exceedingly unlikely and the diagnosis is ordinarily considered to have been excluded at that point, if elevated, we ordinarily pursue the diagnosis of PE with chest CT scanning. For the occasional equivocal result, we next proceed to venous ultrasonography of the legs. If the ultrasonographic examination is normal and high clinical suspicion persists a diagnostic pulmonary angiogram is obtained. An integrated diagnostic strategy that includes clinical probability assessment, chest CT, and venous ultrasonography will usually provide a noninvasive diagnosis or exclusion of PE. This approach is safe, is validated and requires pulmonary angiography in at most 10 percent of patients.,
Rapid D-Dimer Elisa
|
———————-
| |
Normal Elevated
| |
Stop ——— Chest CT———
| | |
| | |
Normal Equivocal Positive
| | |
Stop Ultrasound Treat
|
——————
| |
Negative Positive
| |
PA-Gram Treat
From the bare reading of the above said medical literature, it is apparent that D-Dimer Test is the basic test to find out whether a person is suffering from Pulmonary Embolism or not. If D-Dimer Test is negative then the possibility of Pulmonary Embolism is ruled out and if the report is positive, other tests as mentioned in the table above are to be carried out. Admittedly, the above said algorithms has not been followed for the diagnosis of the disease. The above said algorithms has been provided in standard medical text books and this is a widely accepted algorithms to diagnose the disease. Thus, OPs have failed to follow the widely accepted algorithms for diagnosis of the disease prescribed in the medical text books. So the Pulmonary Embolism was not duly confirmed by the OPs before administering the TPA to the complainant. It amounts to deficiency in service.
21. The next deficiency in service pointed by the learned counsel for the complainant is that the Injection TPA was neither administered by a qualified physician nor a specialist nor was it administered under the supervision of a qualified physician experienced in the use of thrombolytic treatment.
22. The relevant part regarding the use of “TPA Instruction Manual” under the head “special warnings and precautions” reads as under:-
“SPECIAL WARNINGS ARE PRECAUTIONS:-
Actilyse should be used by physician experienced in the use of thrombolytic treatment and with the facilities to monitor that use. As with other thrombolytics, it is recommended that when Actilyse is administered, standard resuscitation equipment and medication be available in all circumstances”.
The side effects under the heading “General disorders and administration site” have been mentioned as under:-
“GENERAL DISORDERS AND ADMINISTRATION SITE”
VERY COMMON : Superficial bleeding, normally from punctures or damaged blood vessels injury and poisoning and procedural complications:-
UNCOMMON: Anaphylactoid reactions which are usually mild, but can be life threatening is isolated cases. They may appear as rash, urticaria, bronchospasm, angio-oedema, hypotesnon, shock or any other symptom associated with allergic reactions. If they occur, conventional anti allergic therapy should be initiated. In such cases a relatively larger proportion of patients were receiving concomitant. Angiotensin Converting Enzymes Inhibitors. No definite anaphylactic (lgE mediated) reactions to Actilyse are known. Transient antibody formation to Actilyse has been observed in rare cases and with low titres, but a clinical relevance of this finding could not be established .
RARE: Cholesterol crcystal embolisation which may lead to corresponding consequences in the organs concerned”.
23. From the bare perusal of the above said portion of the literature printed on the packet insert of the TPA, it is apparent that the actilyse can only be used by an adequately qualified physician well experienced in the use of thrombolytic treatment at a place having the adequate facilities to monitor the follow up procedure.
24. In the present case, Sh.J.S.Arora, the husband of the complainant in his affidavit has deposed that at the time of administration of TPA, no qualified physician experienced and well versed in the use of thrombolytic treatment was present. Nor the facilities to monitor that use were available. Even resuscitation equipment especially the ventilator was not available, as a result of which, the patient had to be compulsorily discharged and taken to Fortis Hospital in a pitiable condition, where ventilator was made available. Our attention has been drawn to the affidavit of Sh.D.S.Gujral (OP-2), wherein it has been mentioned that there was a possible need of ventilator and as there was no ventilator available for the patient/complainant and therefore, she was discharged at the request of the attendants. Dr.Jayant Banerjee (OP-3) in his affidavit has deposed that Dr.Ashutosh Sharma had felt the need of the ventilator for the complainant.
25. Dr.Jayant Banerjee (OP-3) is the main doctor to whom the complainant regularly consulted and under whose supervision, the treatment was given. He has nowhere specifically stated in his affidavit that he was present at the time of administration of the TPA or that the TPA was given under his supervision. On the other hand, he has deposed that Dr.Sudhir Saxena was on routine round, he was consulted and the TPA was administered as per his advice after telling all the pros and cons of the side effects of the TPA to the attendants of the complainant. Dr.Saxena in his affidavit has categorically stated that neither the TPA was administered under his supervision nor was it administered under his advice. Dr.Saxena further categorically stated that he was not present in the OP-Hospital at the time when the TPA was administered. Mr.Daljit Singh Gujral who is the M.D. of the OP-Hospital has also not categorically stated as to who administered the TPA to the complainant. It is pertinent to mention here that Dr.P.S.Mann furnished his affidavit (Annexure C-18) before the Enquiry Committee constituted by Punjab Medical Council and in that affidavit he has stated that the TPA was administered by Kapil Nayer (Staff nurse) under the supervision of Dr.Saxena. To the same effect, is the affidavit (Annexure C-17) of Alveena Samson which was furnished before the Punjab Medical Council. Thus from the above affidavits, it is apparent that there is no categorical stand of OPs as to who exactly and personally administered the injection and as to whether any physician adequately experienced and well versed in the use of thrombolytic treatment was present or not. The qualifications of Kapil Nayer who administered the TPA have not been placed on record. In the written arguments, the stand taken by OPs is that TPA injection had to be transfused to the patient intra veinously through I.V. For this purpose, a central venous catheter was inserted by Dr.Ashutosh. The TPA injection was started at 12.30 p.m. after due consultation between Dr.Jayant Banerjee and Dr.Sudhir Saxena and at that time both the doctors were present in the ICU. The above said document is not supported either by the affidavit of Dr.Banerjee or of the affidavit of Dr.Sudhir Saxena. Dr.Banerjee (OP-3) has categorically stated that he was not present in the hospital at the time of administration of the TPA injection nor the said injection was administered under his supervision. Even Dr.P.S.Mann (OP-4) and Ms.Alveena Samson (OP-5) have not stated that Dr.Banerjee was present at the time when the TPA was administered. Thus, there are lot of contradictions between the stand taken by OPs regarding the presence of the well qualified and specialized doctors at the time of administration of the TPA and regarding the fact as to who administered the TPA to the complainant. It is pertinent to mention here that in the written arguments, the stand taken by the OPs is that there was no need of a consultant or a specialist sitting at the bed side of the patient who is under his care. This stand is in clear contradiction with the instructions mentioned in the relevant medical literature on the TPA reproduced above. In case titled as Dr.Kunal Saha Vs. Dr.Sukumar and Others passed by the Hon’ble Supreme Court of India in Civil Appeal No.1727 of 2007 decided on 07.08.2009, it has been held by the Hon’ble Supreme Court of India that the instructions on the package insert of a drug must be followed by the doctors. Furthermore as mentioned above that, there are several side effects of the TPA so the presence of the qualified doctor or a specialist physician experienced in the use of thrombolytic treatment during the entire process of administration of the injection was necessary as any side effect or complication could occur at the time of administration of the injection and the specialist doctor is needed for diagnosing the side effects and for treating the same on the spot.
26. It is the admitted case of the parties that Dr.P.S.Mann (OP-4) is not a registered medical practitioner with the Punjab Medical Council nor there is any material on record to prove that he has any experience in the use of thrombolytic treatment. He has studied in Gorky”s Donetsk State Medical University from 1997 to 2003. However, he could not pass the screening test, so he is not registered with any Medical Council in India. Thus from the evidence discussed above, it has been duly proved that the injection was not administered by/or under the supervision of a qualified physician, well experienced in the use of thrombolytic treatment or specializing in that line of treatment and with the adequate facilities to monitor the use as also post administration care and treatment. It is a gross negligence on the part of OPs and amounts to serious deficiency in service.
27. The next deficiency in service pointed out by the learned counsel for the complainant is that there is lack of post operative procedure and equipment.
It has been argued by the learned counsel for the complainant that breathlessness and respiratory disorders have been clearly mentioned as the side effects of the administration of the injection TPA (along with other side effects). So it was the duty of the OPs to keep the standby ventilator available in the event of any contingency which might have put the life of the complainant in jeopardy. Our attention has been drawn to the heading “Warnings and Precautions” mentioned in the TPA Administration Manual (Annexure C-10). It has been specifically mentioned that when actilyse is administered, standard resuscitation equipment and medication be kept available in all circumstances. Thus as breathlessness and respiratory disorders are the possible side effects of administration of the TPA. To our mind it was the utmost duty of the OPs to make sure that in case of any breathlessness and respiratory disorders, some equipment for giving adequate help in breathing to the complainant was available. Generally a ventilator is considered to be an essential ICU equipment in order to assist and control pulmonary ventilation in patients who cannot breathe on their own and have other respiratory disorders. This has been clearly mentioned in the medical literature on Intensive Care Unit (Annexure C). In the present case, admittedly no ventilator was available when the condition of the complainant deteriorated and she needed some resuscitation equipment/ventilator for breathing and for other respiratory disorders. OPs failed to keep the ventilator in stand by for the use of the complainant in case the need arose.
28. It was argued by the learned counsel for the OPs that ventilator is not an essential equipment for resuscitation. Our attention has been drawn to the literature issued by National Health Services, wherein ventilator is not mentioned as a necessary equipment for resuscitation. To our mind, the argument advanced by the learned counsel for the OPs is contrary to the facts on record. Admittedly, the complainant was discharged only when no ventilator was made available and the complainant was suffering from breathlessness and respiratory disorders. Admittedly, an option was given to the complainant to shift to a hospital where ventilator was available meaning thereby that real need for ventilator had arisen and the patient had to be discharged from OP-Hospital only because of the non-availability of the ventilator. In fact, mechanical aid in breathing was provided in Fortis Hospital to the complainant on her admission in that hospital as is evident from Annexures C-22 to C-23. Had, the OP-Hospital been in possession of any other instrument of resuscitation, the same could have been put for use and there would have been no need to discharge the complainant from the OP-Hospital in order to avail the facility of ventilator in some other hospital i.e. Fortis Hospital. The act of the OPs to discharge the complainant in a critical condition, due to non-availability of the ventilator itself proves that no proper equipment for resuscitation was available for the use of the complainant.
Admittedly there were several ventilators provided in the hospital, but no ventilator was kept on stand by for the complainant at the time of administration of the TPA so that the same could be used if need arose. This also amounts to professional negligence as well as deficiency in service on the part of OPs.
29. It has been argued by the learned counsel for the OPs that 3 doctors of great repute namely Dr.N.P.Singh, Dr.Jagmohan Verma and Dr.Rupinderjit Singh have already given their opinion that treatment of the complainant was as per the standard medical norms and that no medical negligence is made out. Our attention has been drawn to the opinions and order of Punjab Medical Council Report (Annexure RA-3/9 to Annexure RA-3/12). It is pertinent to mention here that as per the regulations of Indian Medical Council (Professional Conduct Etiquette and Ethics) Regulations, 2002, the Indian Medical Council cannot go into the question of as to whether the doctors have committed any negligence or not or as to whether there was any deficiency in service on their part or not. The professional misconduct have been specifically enumerated in the regulations. The deficiency in service does not form part of the above said Regulations. So even if the Medical council has given an opinion that there is no professional misconduct on the part of OPs, it does not prove that they were not deficient in rendering medical services to the complainant. For the sake of arguments, even if, the opinion given by the above said doctors of the Punjab State Medical Council is accepted, there is nothing on record to show that they had gone into the specific and pertinent issue as to whether i) No proper diagnosis was carried out for confirming pulmonary embolism which would have warranted the administration of the injection TPA in case Pulmonary Embolism was confirmed ii) Whether TPA injection was given by a well qualified physician or a specialist in the said line of treatment or not iii) and whether there was lack of adequacy of Post Operative procedure and equipment or not. So the findings given by the Punjab Medical Council and the opinions of the doctors have no relevance on the merits of this case. As such, the argument advanced by the learned counsel for the OPs on this point has no force.
30. Faced with this situation, it was argued by the learned counsel for the OPs that as has been held in Martin F.D.Souza Vs. Mohd. Ishfaq reported in 2009 (1) CPC-619 (SC), the opinion of the board or of some expert should have been sought regarding the disputed facts as to whether there is any deficiency in service on the part of the doctor or not? To our mind, keeping in view the facts and circumstances of this case, no expert opinion is needed in this case as there is sufficient medical literature as well as a number supporting documents clarifying the position in the entire case. Otherwise also, the present case is at the stage of final hearing and not at the initial stage of issuing notice and, therefore, the above said authority is not applicable to the case in hand.
31. In view of the above findings, this complaint is allowed with following directions:-
i) OPs are directed to refund a sum of Rs.1,01,858/- being the expenses incurred by the complainant upon her treatment in the Inscol Multi-Speciality Hospital, Chandigarh as is evident from Invoice Annexure C-9.
In addition to this, the complainant had to incur expenses to the extent of Rs.6,58,896/- and Rs.32,199/- in the Fortis Hospital, Mohali and PGI, Chandigarh respectively. The complainant had to take further treatment in the said hospitals because of the lapses and deficiency in service on the part of OPs. Annexures C-26 and C-27 are bills showing the said expenditure. So the complainant is entitled to the above said amount of Rs.6,91,095/-. The Ops are, therefore, directed to pay a sum of Rs.6,91,095/- to the complainant.
ii) The complainant has been suffering from mental agony and physical harassment on account of deficiency in service on the part of OPs since the year 2005. So the complainant is entitled to a sum of Rs.10,00,000/- as compensation for mental agony and physical harassment suffered by her. OPs are directed to pay Rs.10,00,000/- to the complainant.
32. This order be complied with jointly and severally by OPs within one month from the date of receipt of its certified copy, failing which the OPs shall be liable to refund the aforesaid total amount of Rs.17,92,953/- to the complainant along with penal interest @ 18% p.a. from the date of filing the complaint i.e. 24.07.2007 till its realization. However, the liability of the insurance company (OP-6) is limited to the extent of insurance Policy No.082401/46/04/01576 issued in favour of Dr.Jayant Banerjee (OP-3) only.
33. Certified copy of this order be communicated to the parties, free of charge. After compliance file be consigned to record room.
Announced
31.12.2009 sd/-
(LAKSHMAN SHARMA)
PRESIDENT
Sd/-
(ASHOK RAJ BHANDARI)
MEMBER