National Consumer Disputes Redressal
Dr. Jayant Banerji vs Smt. Inderjit Arora & Ors. on 10 April, 2017
NATIONAL CONSUMER DISPUTES REDRESSAL COMMISSION NEW DELHI REVISION PETITION NO. 323 OF 2011 (Against the Order dated 06/12/2010 in Appeal No. 50/2010 of the State Commission Chandigarh) WITH MA/194/2012,IA/1393/2016,IA/2282/2013,IA/2847/2015,IA/3432/2015,IA/5751/2014 1. INSCOL HOSPITAL & ANR. Through its Director Mr. Daljit Singh, SCO No. 18-19, Sector 34-A Chandigarh 2. MR. DALJIT SINGH GUJRAL, MANAGING DIRECTOR, INSCOL HEALTHCARE LTD. SCO No. 18-19, Sector 34-A Chandigarh ...........Petitioner(s) Versus 1. INDERJIT ARORA & ORS. Resident of 6183, Modern Housing Complex, Manimajra Chandigarh 2. DR. JAYANT BANERJEE, INSCOL HEALTHCARE LTD. SCO No. 18-19, Sector 34-A Chandigarh 3. MS. ALVEENA SAMSON House No. 843, Phase IV Mohali Punjab 4. UNITED INDIA INSURANCE COMPANY LIMITED Through its Manager, SCO No. 123-124, Sector 17-B Chandigarh 5. SH. P.S. MANN, INSCOL HEALTHCARE LTD. SCO No. 18-19, Sector 34-A Chandigarh ...........Respondent(s) REVISION PETITION NO. 1650 OF 2011 (Against the Order dated 06/12/2010 in Appeal No. 49/2010 of the State Commission Chandigarh) WITH
MA/194/2012,IA/1393/2016,IA/2282/2013,IA/2847/2015,IA/3432/2015,IA/5751/2014 1. DR. JAYANT BANERJI Resident of 14, Deakin Drive Flora Hill VIC Australia ...........Petitioner(s) Versus 1. SMT. INDERJIT ARORA & ORS. R/o. 6183, Modern Housing Complex, Manimajra Chandigarh 2. INSCOL MULTI-SPECILAITY HOSPITAL Through its Managing Director, SH. Daljit Singh Gujral, Sector 24-A Chandigarh 3. SH. DALJIT SINGH GUJRAL, MANAGING DIRECTOR, INSCOL MULTI-SPECILAITY HOSPITAL Sector 24-A Chandigarh 4. P.S. MANN, INSCOL MULTI-SPECILAITY HOSPITAL Sector 24-A Chandigarh 5. MRS. ALVEENA SAMSON, ASST. NURSING, SUPERINTENDING, INSCOL MULTI-SPECILAITY HOSPITAL Sector 24-A Chandigarh 6. UNITED INDIA INSURANCE COMPANY LIMITED Through its Manager, SCO No. 123-124, Sector 17-B Chandigarh ...........Respondent(s) BEFORE: HON'BLE MR. JUSTICE D.K. JAIN,PRESIDENT HON'BLE MRS. M. SHREESHA,MEMBER For the Petitioner : Mr.ArvindNayyar and Ms.Runasree Buragohain, Advocates For the Respondent : Mr. J.S. Arora, Authorized Representative of R-1 Mr.M.N. Singh, Advocate for Insurance Dated : 10 Apr 2017 ORDER PER MRS. M. SHREESHA, PRESIDING MEMBER Challenge in these Revision Petitions under section 21(b) of the Consumer Protection Act, 1986 (in short the Act), is to the order dated 06.12.2010 in Appeal Nos. 48,49 and 50 of 2010 passed by the State Consumer Disputes Redressal Commission, U.T. Chandigarh (in short the State Commission).By the impugned order, the State Commission dismissed all the three appeals preferred by the Opposite Parties, confirming the order passed by the District Consumer Disputes Redressal Forum-II, U.T. Chandigarh(in short the District Forum).
2. For the sake of convenience, the Opposite Parties are hereinafter referred to as they had been arrayed in the main Complaint viz. 1. Inscol Hospital, 2. Mr. Daljit Singh Gujral, 3. Dr. Jayant Banerjee, 4. Sh. P.S. Mann, 5. Mrs. Alveena Samson and 6. Unite India Insurance Co.
3. The facts, material to the case, are that the Complainant, aged 61 years, a diabetic for the last 10 years, was under the medical supervision of the third Opposite Party for the last 7 years. The Complainant visited the clinic of the third Opposite Party at 4 p.m. on 01.08.20105 with a complaint of fever, breathlessness and severe pain in her left leg for which she was prescribed certain preliminary tests to be carried out at Prime Diagnostic Centre. A high resolution Harmonic Echo Cardiology was performed on the Complainant. Thereafter she was referred by the third Opposite Party to Cardiologist, Dr. Sudhir Saxena, who advised hospitalization and conduction of investigations viz. D-Dimer Test, Repeat Echo Test and Spiral CT Chest Scan for confirming suspected Pulmonary Embolism. He prescribed some medicines and left the rest of the treatment to the third Opposite Party.
4. Acting upon the advice given by Dr. Sudhir Saxena and the third Opposite Party, the Complainant got admitted in the Intensive Care Unit (I.C.U.) of the first Opposite Party. It was averred that despite a specific mention in the prescription slip issued by Dr. Sudhir Saxena, none of the tests suggested by him were carried out and only the routine tests like Ultra Sound and Colour Doppler were conducted. During the Complainant's overnight stay in the I.C.U., her blood pressure was recorded as 130/70 and she was administered injections like Clivarne, Ranitidine, Diclofenac, Augpen, etc. It was stated that in the I.C.U. report dated 01.08.2005 issued by the first Opposite Party, that from the time of her admission in the I.C.U., till 6 a.m. on 02.08.2005, her blood pressure varied between 110/80 to 120/80 which is medically considered to be normal. In the morning of 02.08.2005, it was brought to the notice of the family members that the Complainant's condition had deteriorated to quite an extent, as a result of which, it was recommended by the concerned authorities of the first Opposite Party that an injection, namely TPA, Tissue Plasmogim Activator (Actilyse), was required to be administered to the Complainant. The said injection was requisitioned from one M/s. Kapoor& Company for immediate supply of two injections of Actilyse 50 Mgm. An amount of ₹72,000/- vide invoice dated 02.08.2005 was paid by the Complainant's husband for the said injection.
5. It was pleaded that the exact time of the administration of the said injection does not find a mention in the I.C.U. report and that the entry in the hospital record reflects that injection TPA 100 Mg. had been administered to the Complainant over a period of two hours from 9 to 11 a.m., which is contrary to what has been stated by the supplier of the subject injection that it was delivered to the first Opposite Party Hospital at 12:30 p.m. on 02.08.2005. It was averred that in the light of the deposition made by Shri Raj Pal Kapoor who had supplied the said injection, the administration of TPA between 9 to 11 a.m. was doubtful. It was further pleaded that even if the TPA had in fact been administered to the Complainant, they were negligent in their professional expertise, which was required to be exhibited while attending to such grave cases involving suspected Pulmonary Embolism. The TPA is not supposed to be administered to any patient at a time when she is being given doses of other injections, meaning thereby, that the administration of TPA is not to be accompanied by the administration of other injections which might have a negative effect on the medical health of the patient, making her more prone to side effects. It was pleaded that the medical literature of the injection TPA shows that it has to be given only in cases of (a) Acute Heart Attack, (b) Acute Stroke patients and (c) Acute Pulmonary Embolism. The diagnosis should be confirmed by objective means like Pulmonary Angiography or non-invasive procedures such as lung scan. It was stated that the medical literature also reveals that prior to administration of the injection TPA, a number of tests namely (a) CT Scan, (b) Pulmonary Angiogram Test and (c) Venous Doppler Test, are required to be carried out for confirming the diagnosis which was not done in the instant case, despite the advice by Dr. Sudhir Saxena.
6. It was pleaded that in the TPA manual under the head of 'Special Precautions', it has been specifically provided that Actilyse ought to be administered by physicians experienced in the use of Thrombolytic treatment in the presence of facilities required thereof to monitor the case. It was also provided therein that when Actilyse is administered to a patient, standard resuscitation equipment and medication should be made available in all circumstances. It was pleaded that none of the detailed precautions were observed by the authorities. For example, the time when the TPA injection was administered to the Complainant, there was no ventilator available which could have been summoned by the Hospital authorities in the eventuality of any complication. TPA is to be dispensed under the supervision of a specialist as internal and external bleeding can be caused and no such instruction was carried in this case. It was further pleaded by the Complainant that the third Opposite Party had sent a letter dated 27.10.2005 to the Complainant's husband wherein it was stated that the clot bursting injection was given by Dr. Sudhir Saxena after Dr. U.P. Singh too confirmed the diagnosis of Pulmonary Embolism, pursuant to a test allegedly carried out in the Fortis Hospital on 01.08.2005. It was stated by the Complainant that the confirmation made by the third Opposite Party in his letter dated 27.10.2005, that TPA was given by Dr. SudhirSaxena, was extremely doubtful in the light of his deposition in the affidavit dated 14.07.2006 and letter dated 07.11.2006, wherein, he specifically mentioned that the injection Actilyse was neither given to the Complainant under his care nor was he present at the time when the procedure of giving the injection was carried out in the premises of the first Opposite Party. Dr. Sudhir Saxena further deposed in the affidavit that he was never engaged as a consultant of the first Opposite Party for the purpose of attending to the Complainant and also that he was not paid any remuneration for the said consultation. Furthermore, the test allegedly carried out in the Fortis Hospital on 01.08.2005 which finds mention in the letter dated 27.10.2005 issued by the third Opposite Party, was also an afterthought in so far as the conduction of the D-Dimer Test was concerned as the letter stated that the test was conducted on 07.08.2005, on which date, the Complainant was no longer a patient of the first Opposite Party. It was pleaded that the D-Dimer Test report received from Fortis Laboratory on 07.08.2005, shows the date of sample drawn as 08.07.2005 and the date of printing as 07.11.2005. This report was issued on the reference of Dr. Ashit Single and could not be legally taken into consideration as the same reflected the efforts made on behalf of the Opposite Parties in procuring a false and fabricated report.
7. It was further stated that the stand of the Opposite Parties regarding the administration of TPA is conflicting and the concerned authorities have adopted different perspective as is made out in the affidavit of the fifth Opposite Party, who submitted before the Punjab Medical Council, that she was working as an Assistant Nursing Superintendent with the first Opposite Party and was on duty on 02.08.2005 and deposed that the injection Actilyse was given under the supervision of Dr. Sudhir Saxena to the Complainant by one Kapil Nayyar (staff nurse). This was further corroborated by the affidavit given by the fourth Opposite Party who supported the same viewpoint. The affidavit dated 14.07.2006 by Dr. Sudhir Saxena claims that he was not present at the time when the TPA injection was administered. It was pleaded that TPA was not given to the Complainant by a specialist Doctor nor was it supervised with the necessary precautions required to be borne in mind and on account of this negligence the Complainant was made to suffer for a period of more than six months and her mobility was extremely restricted which in turn caused great loss, physical pain, harassment and mental agony to the Complainant.
8. It was averred that A perusal of the I.C.U. report dated 02.08.2005 issued by the first Opposite Party showed a steep decline in the Complainant's Blood Pressure levels which are reproduced as under:
"2.8.05 Time Blood Pressure 8.00 A.M. 100/60 9.00 A.M. 90/50 10.00 A.M. 80/P 11.00 A.M. 80/P 12.00 noon 88/p 1.00 P.M. 90/50 2.00 P.M. 94/50 3.00 P.M. 80/P 4.00 P.M. 70/50 5.00 P.M. 72/60 6.00 P.M. 76/54 6.40 P.M. 70/50
9. Apart from suffering from breathlessness, the Complainant also sustained boils and rashes on her entire body which turned to oedema and by the time she was admitted in Fortis Hospital she was in a state of shock. It was averred that after being discharged on 12.09.2005, she was again admitted on 14.09.2005 in Fortis Hospital on account of her failing health and was kept under observation as an indoor patient till 22.09.2005. It was stated that the chain of events starting from the cause of the deteriorating medical condition and culminating in the Complainant's physical disability is only because of the improper treatment and medical negligence of the Opposite Parties. After discharge from the Fortis Hospital on 22.09.2005, the Complainant was also admitted in Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh as an indoor patient and has suffered severe physical and mental agony which has affected her social life.
10. It was further pleaded that the fourth Opposite Party was not a qualified medical practitioner in so far as his degree was not recognized by the Medical Council of India and therefore he cannot be considered as a Specialist and TPA might not have been administered under his supervision. The complainant and her family members have suffered enormously due to the negligence and deficiency in the discharge of services by the Opposite Parties and have suffered immense physical and financial loss. Hence the Complaint, seeking direction to the Opposite Parties to pay an amount of ₹20,00,000/-, detailed hereunder:-
"DETAILED EXPENSES Particulars Amount Medical Expenses:₹8,00,000/- (Annexure C-26 & C-27 and C-9)(including cost of medicines) Loss of income of the Complainant₹3000 X 12 X 5 = 1,80,000/-
Expenses incurred on hiring a maid servant to look after the complainant ₹81,500/- (Annexure C-28) (till July,2007) Expenses incurred on providing food, shelter and clothing to the maid. ₹36000/- (1500/- per month)
Exemplary compensation for the mental agony, distress, pain suffered by the complainant on account of the negligence of the opposite parties No. 1 to 5, which resulted in the deteriorating medical condition of the complainant is being claimed to be ₹9,00,000/-
____________ Total Compensation claimed: ₹20,00,000/-."
11. The first and second Opposite Parties representing the Hospital, filed their Written Version denying that there was any negligence or deficiency in service on their behalf and averred that the Complainant was treated by the Doctor of her choice; proper assistance and facilities were provided by the Hospital staff; in addition to the tests specified by the Complainant, D-Dimer Test was also done confirming the diagnosis of Pulmonary Embolism; the Complainant was treated as per the advice and supervision of the third Opposite Party and Dr. Sudhir Saxena only after the D-Dimer Test confirmed the diagnosis and therefore, Spiral CT Chest and Repeat Echo were not considered necessary. Medicines as prescribed by the treating doctors were given and constant monitoring was also done. It was only on the advice of the third Opposite Party and observing the falling Blood Pressure levels, that TPA was requisitioned and administered to the Complainant. All precautions including regular monitoring was done while administering TPA which is evident from the treatment record. Dr. Sudhir Saxena himself attended to the patient which is evident form his hand written notes in the treatment chart.
12. It was averred that ventilators were available in the Hospital but when the need arose, the same could not be provided as they were being used by other patients and this was immediately brought to the notice of the Complainant and her attendants so that alternative arrangements could be made. Doparin and Debumin were also given. Any deterioration in the Complainant's condition in Fortis Hospital and thereafter in PGIMER cannot be attributed to them.
13. It was denied that Dr. P.S. Mann was not a duly qualified doctor to supervise the administration of TPA. It was stated that he was only acting under the instructions of the third Opposite Party and Dr. Sudhir Saxena and was himself not the treating physician. It was pleaded that all practices under normal medical parlance were followed and no medical negligence can be attributed to them.
14. The third Opposite Party filed his Written Version stating that the Complainant was his patient since 7 years and had approached him earlier with symptoms of hypertension and diabetes with neuropathy. She had gangrene of the toe and was never regular in her visits and would come only once or twice a year. She was satisfied with the treatment and was visiting his clinic over many years. While so, on 01.08.2005 the Complainant approached his clinic with fever, sweating and breathlessness and complained of infection on her left shin for which she was self-medicating with antibiotics since many days prior to this visit. These facts were written on her OPD card which was in her possession, but not annexed with the Complaint. ECG test was performed, which showed her right bundle branch block clearly suggesting Pulmonary Embolism from the deep vein in her infected left leg and she was advised to get an Echo Cardiogram done. Dr. U.P. Singh (DM Cardiology) called this Opposite Party and suggested that the Complainant had Pulmonary Hypertension with normal right ventricular size suggesting Embolism. Immediately the Complainant was advised to visit Dr. Sudhir Saxena, a Consultant Cardiologist at the first Opposite Party Hospital. On Dr. Sudhir Saxena's advice, the Complainant was admitted in first Opposite Party Hospital and was put on low molecular weight heparin therapy. An Ultrasound Doppler and D-Dimer Tests were done and she was treated with antibiotics for her infection. 1/V fluid was started, insulin was given for high blood sugar and oxygen for low saturation. Dr. Sudhir Saxena was informed telephonically that the patient's condition did not improve and he administered the injection after explaining to the Complainant and her attendants of the pros and cons and taking their consent. However, the Complainant's Blood Pressure and oxygen continued to fall so Central venous line (CVP) was put and when CVP was found to be high, the necessity for ventilator was felt by Dr. Ashutosh Sharma (Staff Member of first Opposite Party).But all the ventilators in the Hospital were occupied at the relevant time and the Complainant was given an option of being shifted to another Hospital. Thereafter the Complainant was shifted to Fortis Hospital at their own choice.
15. Complainant was shifted only in anticipation of a need of ventilator and after making adequate arrangements. Complainant had received ideal treatment with perfect clinical diagnosis, ECG, ECHO, Doppler, D-Dimer and specialist cardiologist referral were all conducted within two to three hours. The costs were explained and no payment whatsoever has been made to the third Opposite Party. The Complainant was treated better than a family member and a well evaluated plan of treatment was implemented and carried out to save the life of the Complainant. Punjab Medical Council has considered the Complaint against the third Opposite Party and exonerated him of any negligence whatsoever. It was pleaded that the affidavit filed by Mr. Raj Pal Kapoor was frivolous and that the original bills for the said injection were with the first Opposite Party Hospital.
16. It was averred that the Complainant at the relevant time was suffering from low Blood Pressure, worsening with every moment, clearly indicating Pulmonary Embolism. The diagnosis of Pulmonary Embolism was confirmed not only by Dr. U.P. Singh and Dr. Sudhir Saxena but also by the supporting staff of Fortis Hospital where the patient was further treated. It was pleaded that the averments made by Dr. Sudhir Saxena in his affidavit are wrong and in fact the Complaint is bad for non-joinder of Dr. Sudhir Saxena. It was also stated that the Complainant had completely misunderstood the medical literature on the subject and the interpretation given by her is not as per the prescribed standards. In fact the Medical Council, a body comprising of qualified professionals and experts on the subject, found this Opposite Party not negligent. He further submits that all proper procedures were followed while administering the subject injection and no medical negligence can be attributed to him.
17. The fourth Opposite Party, Dr. P.S. Mann adopted the Written Version filed by the first and second Opposite Party and pleaded that the D-Dimer test was carried out before administering the TPA and that the treatment was given as per the directions of the treating doctors. He further averred that he possessed the recognized medical qualifications and that there was no deficiency of service on his part.
18. The fifth Opposite Party, Ms. Alveena Samson, Assistant Nursing Superintendent of the first Opposite Party did not appear before the District Forum, despite service of notice and was proceeded ex-parte, vide order dated 11.10.2007.
19. The sixth Opposite Party, United India Insurance Company filed their Written Version stating that only the third Opposite Party i.e. Dr. Jayant Banerji was insured under Policy No. 082401/46/04/01576 for the period 05.03.2005 to 04.03.2006. It was averred that there was no negligence on behalf of the third Opposite Party and hence the Complaint qua the third Opposite Party deserves dismissal and that the sixth Opposite Party cannot be made liable to indemnify the other Opposite Parties who are not insured with it.
20. The District forum relying on the medical literature " Brounwalds Heart Disease, A Textbook of Cardiovascular Medicine 7th edition" observed that D- Dimer test was the basic test to find out whether a person was suffering from Pulmonary Embolism or not and the algorithms provided in the medical textbook have not been followed by the Opposite Parties and therefore Pulmonary Embolism was not duly confirmed before administering TPA to the Complainant. The District Forum, relying on the denial of the Dr. Sudhir Saxena in his affidavit, the statement of Dr. P.S. Mann that the TPA was administered by the staff nurse, Kapil Nayyar, whose qualification has not been placed on record, the absence of the deposition in the affidavit of Dr. Jayant Banerji and Dr. Sudhir Saxena that they were present at the time of the administration of the TPA, held that, Opposite Parties were negligent in not following standards of normal medical practices during administration of TPA.
21. As regards the opinion of the Punjab Medical Council the District forum held as follows:
"29. 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 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. To our mind, keeping in view the facts and circumstance of this case, no expert opinion is needed in this case as there is sufficient medical literature as well as a number of 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:-
Ops are directed to refund a sum of 1,01,858/- being the expenses incurred by the complaiant 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 ₹ 6,58,896/- and ₹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. Annexure C-26 and C-27 are bills showing the said expenditure. So the complainant is entitled to the above said amount of ₹6,91,095/-. The Ops are, therefore, directed to pay a sum of ₹6,91,095/- to the complainant.
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 ₹10,00,000/- as compensation for mental agony and physical harassment suffered by her. Ops are directed to pay ₹10,00,000/- to the complainant.
32. This order be complied with jointly and severally by the 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 ₹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."
22. Aggrieved by the said order the sixth Opposite Party, Insurance Company, the third Opposite Party, Dr. Jayant Banerji and the first, second and fourth Opposite Parties preferred Appeal Nos. 48, 49 & 50 of 2010 respectively before the State Commission.
23. The State Commission while holding that there is no merit in any of the appeals modified the amounts to be paid and directed as hereunder:
"We are, therefore, of the opinion that out of the entire amount ordered by the learned District forum, 50% shall be paid by Dr. Jayant Banerji (OP No. 3 and the Insurance Company-OP No. 6) and the remaining 50% shall be paid equally by Ops No. 1 and 2. We do not find much against Ops No. 4 and 5 to burden them with the liability of paying the compensation."
24. Heard the Petitioners and Respondents at length.
25. Defining the 'Duty of Care' to be followed by medical practitioners, the Hon'ble Supreme court in Laxman Balakrishna Joshi Vs. Trimbak Bapu Godbole & Anr., 1969 (1) SCR 206 has held as follows:
"The duties which a doctor owes to his patient are clear. A person who holds himself out ready to give medical advice and treatment impliedly undertakes that he is possessed of skill and knowledge for the purpose. Such a person when consulted by a patient owes him certain duties, viz., a duty of care in deciding whether to undertake the case, a duty of care in deciding what treatment to give or a duty of care in the administration of that treatment. A breach of any of those, duties gives a right of action for negligence to, the patient. The practitioner must bring to his task a reasonable degree of skill and knowledge and must exercise a reasonable degree of care. Neither the very highest nor a very low degree of care and competence judged in the light of the particular circumstances of each case is what the law require."
We address ourselves to whether this 'Standard of Care' has been adhered to by the Petitioners herein.
Whether the Investigations advised by Dr. Sudhir Saxena viz., (i) D-Dimer Test. (ii) Repeat Pulmonary Artery Pressure and (iii) Spiral CT Chest Scan, were performed prior to confirmation of Pulmonary Embolism.
Whether D-Dimer Test was conducted on 01.08.2005 or on 07.08.2005.
Whether diagnosis of Pulmonary Embolism could be based on D-Dimer Test alone and whether the result was interpreted properly.
Whether the decision to administer TPA, was right taking into consideration the Complainant's clinical condition at that point of time.
Whether the administration of TPA was done under the supervision of qualified specialists as per the standard norms of medical practice.
Whether non-availability of ventilator at that point of time can be construed to be negligence on the part of the Doctors.
Whether the records sought for by the Complainant were given by the Opposite Parties
26. It is the main case of the Complainant that Dr. Sudhir Saxena on 01.08.2005 advised investigations namely D-Dimer, Repeat Echo for Pulmonary Artery Pressures and Spiral CT Chest Scan. A brief perusal of the prescription of Dr. Sudhir Saxena, evidences the same. He has also advised hospitalization and noted that the rest of the treatment was to be given as advised by Dr. Jayant Banerji. In the said prescription he has observed under the head 'PLAN' that IVC filter is necessary after confirmation. There is a laboratory report dated 01.08.2005, 11:30 p.m. specifying that the D- Dimer test was conducted and that the D-dimer Plasma was out of range i.e., it was between 0.8 to 1.6, whereas the reference range was less than 0.20 MG/L. The Complainant's husband, arguing on behalf of his wife, brought to our notice another laboratory report by Fortis Hospital dated 07.08.2005/ 08.07.2005 which is stated to have been procured under RTI. It is the case of the Complainant that D-Dimer Rest was not conducted on 01.08.2005 and even if it had been conducted it was not a conclusive test for diagnosing Pulmonary Embolism. The Learned counsel representing Inscol Hospital vehemently argued that D-Dimer Test was conducted as can be seen from the report dated 01.08.2005 and this was the conclusive test for Pulmonary Embolism and therefore spiral CT Chest Scan was not necessary. As against this, the Complainant's argument was that as per the letter received from Fortis Hospital, D-Dimer Test was conducted onlyon 07.08.2005 and not on 01.08.2005, and even for argument's sake had the test been conducted on 01.08.2005, the same would have been reflected in the case sheet. It was also contended that no charge for conducting the D-Dimer test was recovered from the Complainant and if the Opposite Parties had paid ₹1,000/- to Fortis Hospital for D-Dimer test they would have mentioned the same in the statement of bills prepared in this case. It was argued by the Counsel representing the Hospital that ₹1,000/- was charged for the D-Dimer test and the same was included in the laboratory investigation charges. Both the fora below have concurrently found that had the D-Dimer test been done on 01.08.2005 the same would have been specifically mentioned in the receipt.
27. A perusal of the report of the Punjab Medical Council does not specify that the said test was conducted and if the report dated 01.08.2005 was furnished to them. Only one report dated 07.08.2005 was submitted. There was no explanation given by the Hospital as to why the report dated 01.08.2005 was not furnished if it was available with them at that point of time. The State Commission has observed that the Blood Samples received for D-Dimer Test would have been prepared and entered in some register maintained by Fortis Hospital and the reports thereof would also have been entered serial wise which evidence could have been produced by the Opposite Parties to prove that such a sample was received on 01.08.2005 and was analyzed by them. However, no such evidence was led by the Hospital or doctors despite the main contention of the Complainant that the D-Dimer test was never performed.
28. Even for sake of arguments if the D-Dimer test was indeed conducted, it is the case of the Complainant that it is not a Conclusive one and that the Spiral CT Chest Scan and Venous Doppler, also advised by Dr. Sudhir Saxena, ought to have been performed to confirm the Diagnosis.
29. For better understanding of the nature of the test, D-Dimer test report is reproduced hereunder:
" Date: 01.08.2005 Patient Name: Inderjeet Kaur; Client Patient ID: FHL 10000079400 Age 60 years; Sex: Female Clinical Information Final test report status Result Reference Units Range D-Dimer D-Dimer 0.8-106 <0.20 mg/L D-Dimer Plasma The level of D-Dimer raises during the coagulation activation state. It is photolytic product of cross-linked fibrinogen. Increased levels of D-Dimer have been reported in the following cases: deep vein thrombosis (DVT), embolism, DIC<haemorrhages, surgery, cancers and cirrhosis of liver. The D-Dimer level generally rises in the first 2 to 3 days post-operatively, and this is an evidence of the fibrinolytic activity directed against the enhanced levies of fibrin produced as a result of surgery. Thus, a high D-dimer level is an expected immediately after the surgery. If the elevated D-Dimer level persists, or tends to rise further, then this a warning sign of an impending or an ongoing thromboembolic episode.
Test method: Latex agglutination slide test.
****End of Report***."
30. Comparison of both the reports dated 01.08.2005 and 07.08.2005 prima facie shows that the aforementioned text was missing in the second report dated 07.08.2005. A letter dated 08.12..2007 was addressed to the Medical Director, Fortis Hospital by the Complainant seeking verification of the authenticity of the laboratory report printed on 07.11.2005. In response to that letter it is interesting to read the reply of Fortis Hospital which is as follows:
"The Hospital did not issue two D-dimer reports. Only one D-Dimer report dated August 7,2005 was issued by the Hospital and the original of the same was given to Mr. JS Arora."
31. It is the Complainant's case that the Hospital had obtained a duplicate D-Dimer test report from the Court of JMIC Chandigarh and this is being used to establish the genuineness of the test.
32. It was alleged by the Complainant that the laboratory report dated 07.08.2005 specifies that the test does not come under NABL accreditation scope of the laboratory and this notation of NABL was deliberately erased by the doctors from the test report dated 01.08.2005. Be that as it may, even for the sake of argument if the D-Dimer Test had indeed been conducted, whether it requires a Repeat Echo and Spiral CT Chest Scan, with Venous Doppler has to be ascertained.
33. "Brounwalds Heart Disease", A Textbook of Cardiovascular Medicine 7th edition defines Pulmonary Embolism, the "Diagnosis" and the "Investigations" to be conducted for its treatment:
"TABLE 66-6 SIX Syndrome of Acute Pulmonary Embolism Syndrome Presentation Right Ventricular dysfunction Therapy Massive Breathlessness, syncope, and cyanosis with persistent systemic arterial hypotension; typically>50 percent obstruction of pulmonary vasculature Present Heparin plus thrombolytic therapy or mechanical intervention Moderate to large ("submissive") Normal systemic arterial blood pressure; typically>30 percent perfusion defect on lung scan Absent Heparin plus or minus thrombolytic therapy or mechanical intervention Small to moderate Normal arterial blood pressure Rare Heparin Pulmonary infarction Pleuritic chest pain, hemoptysis, pleural rub, or evidence of lung consolidation typically small peripheral emboli Rare Heparin and nonsteroidal anti-inflammatory drugs Paradoxical embolism Sudden systemic embolic event such as stroke Rare Anticoagulation + closure of right-to-left cardiac shunt Nonthrombotic embolism Most commonly air, fat, tumor fragments, or amniotic fluid Rare Supportive *therapy depends on degree of impairment of right ventricular function and presence or absence of contraindications to thrombolysis or heparin. Adapted from Goldhaber SZ: Treatment of acute pulmonary embolism. In Goldhaber SZ(ed): Cardiopulmonary Diseases and Cardiac Tumors. In Braunwald E (series ed): Atlas of Heart Diseases. Vol3. Philadelphia, Current Medicine, 1995 pp7.1-7.12.
Nonimaging Diagnostic Methods To establish the diagnosis of PE, the astute clinician must first suspect this illness. Establishing the clinical probability of PE is important to help decide which patients should undergo further work-up. Many patients in whom PE is a theoretical possibility are exceedingly unlikely to have PE.
PLASMA D-DIMER ELISA. This blood-screening test relies on the principle that most patients with PE have ongoing endogenous fibrinolysis that is not affective enough to prevent PE but that does break down some of the fibrin clot to D-Dimers. Although elevated plasma concentration of D-dimers are sensitive for the presence of PE, they are not specific. Levels are elevated in patients for at least one week postoperatively and are aslo increased in patient with myocardial infarction, sepsis, cancer, or almost any other systemic illness, therefore, the plasma D-dimer ELISA is ideally suited for outpatients or Emergency Department patients who have suspected PE but no coexisting acute systemic illness. This test is not useful for hospitalized inpatients.
CHEST COMPUTED TOMOGRAPHY. Chest CT has supplanted pulmonary radionuclide perfusion scintigraphy of the initial imaging test in most patients with suspected PE(Fig. 66-7).53a For patients with intrinsic lung disease and abnormal chest radiograph results. The chest CT scan can suggest an alternative or concomitant pulmonary disease to explain the clinical presentation. For the evaluation of suspected PE, the CT examination can include scanning of the venous system from the popliteal veins to the sub segmental pulmonary arteries. The CT examination can also provide valuable information about the size and function of the right ventricle relative to the left and can alert the clinician to the presence of right ventricular dysfunction. The latest generation of multidetector-row CT scanners permits image acquisition of the entire chest with 1mm or submillimeterresolution with a breath-hold of less than 10 seconds.54 With a properly performed CT scan on a multidetector row machine, it is likely that CT scanning supplants pulmonary angiography as the gold standards for PE imaging.
We obtain an electrocardiogram and chest radiograph. To screen for PE in the Emergency Department, we obtain a rapid turn-around plasma D-dimer ELISA if normal, then PE is exceedingly unlikely, and that point. If elevated, we ordinarily pursue the diagnosis of PE with chest CT scanning. For the occasional equivocal result, we next TABLE 66-8 Advantages and Disadvantages of Diagnostic Tests for Suspected Pulmonary Embolism Diagnostic Test Advantages Disadvantages Plasma D-dimer Elisa A normal result in this rapid turnaround blood test makes PE exceedingly unlikely.
Level is elevated in patients with many systemic illnesses that mimic PE, such as pneumonia and myocardial infraction. Level is elevated in patients with sepsis, cancer, postoperative sate, and pregnancy.
Electrocardiograms Universally available; may indicate ominous acute corpulmonale or benign pericarditis Acute corpulmonale on electrocardiogram is not specific for PE; not a sensitive test.
Chest radiograph Usually has minor abnormalities but occasionally pathognomic; may indicate alternative diagnoses such as pneumothorax.
Not specific Chest computed tomography New-generation scanners constitute the new gold standard for diagnosis Older generation scanners are insensitive of important but distal PE.
Lung Scanning High-probability scans are reliable for detecting PE; normal/ near normal scans are reliable for excluding PE.
Most scans are neither high probability nor normal/ near-normal; lung scans are falling out of favor; most test results are equivocal.
Magnetic resonance imaging Excellent for anatomy and cardiac function; the contrast agent does not cause renal failure In preliminary use; not widely available; experience very limited Echocardiography Excellent for identifying right ventricular dilation and dysfunction that is not obvious clinically, thus providing an early warning of potentially adverse outcome.
Not specific; many patients with PE have normal echocardiograms; the test cannot reliably differentiate causes of right ventricular dysfunction.
Pulmonary angiography Necessary for catheter-based interventions.
Invasive, costly, uncomfortable.
Venous ultrasonography Excellent for detecting symptomatic proximal DVT; surrogate for PE.
Cannot image iliac vein thrombosis; imaging of calf is operator dependent; DVT may have embolized completely, resulting in normal finding.
Contrast venography Used to be gold standard; excellent for calf veins; necessary for catheter-based interventions Can cause chemical phlebitis; uncomfortable; costly; may fail to diagnose massive DVT because veins are filled with thrombus and cannot be opacified.
DVT+ deep venous thrombosis; ELISA enzyme-linked immunosorbent assay; PE= pulmonary embolism.
Proceed to venous ultrasonography of the legs. If the ultra sonographic 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. 68"
34. From the aforementioned Literature it is clear that in a D-Dimer Test although elevated plasma concentration are sensitive for the presence of Pulmonary Embolism, they are not specific; levels are elevated in patients for at least one week postoperatively increased in patients with myocardial infarction, sepsis etc; this test is not useful for hospitalized inpatients. The medical literature clearly substantiates what Dr. Sudhir Saxena had initially recorded in his prescription that a chest CT should also be conducted. The literature specifies that CT scanning Supplants Pulmonary Angiography as the gold standard for PE imaging. The record shows that this CT Chest Scan was not conducted together with the D-Dimer Test and therefore we hold that diagnosis of Pulmonary Embolism could not have been conclusive by conducting D-Dimer Test alone.
35. Now we address ourselves to whether administration of TPA was the right decision for the treatment and also whether it was under the supervision of a Specialist as stipulated by the standards of normal medical practices. Learned Counsel representing the Hospital vehemently argued that TPA was the right treatment to have been administered for a patient suffering from Pulmonary Embolism and that the administration of TPA was closely monitored by Dr. Jayant Banerji and his team and was reviewed by Dr. Sudhir Saxena. A brief perusal of the case sheet shows that the Complainant was a known case of Diabetes Mellitus type 2 and was suffering from Cellulitis of the legs on 01.08.2005. ECG and Echo were performed. Ultrasound of the abdomen, D-Dimer and Venous Doppler test of the lower limb were also advised. The case sheet does not anywhere reflect the result of the lower limb Venous Doppler Test, which is again stated in the medical literature to be the gold standard for diagnosing Pulmonary Embolism.
36. On 02.08.2005, the progress chart shows that the case was reviewed by Dr. Sudhir Saxena and Dr. Jayant Banerji and that TPA and Actilyse 50 mcg were to be given over a period of one hour and the next 50 mcg to be given over another hour. At 3 p.m. on the same date, it was admittedly noted by Dr. Jayant Banerji that the patient may have PTE/Sepsis, low SPO-2, Hypotension and needs ventilator support and that as no ventilator was immediately available, the Complainant's attendants were explained of the risk and options of shifting to higher Management Centre. The Hospital treatment record shows that injection TPA was administered over a period of 2 hours but the exact time was not noted. The Learned Counsel submitted that TPA was started around 12 noon, and that other investigations viz. Urine, ECG, ABG, ESR, Serum creatinine and platelets were done at 5 p.m. The discharge bill dated 02.08.2005, though, specifies in detail the medicines including syringes oxygen mask etc. does not state as to when TPA was purchased and if, it was included in the Patient's bill. It is the main case of the Complainant that the TPA injection was sourced from outside by him, but it was still billed by the Hospital for ₹72,000/-. The case sheet does not anywhere specify as who was the duty doctor monitoring the careful administration of TPA, which is required under standard normal practices. It can be seen from the medical literature under Warnings and Precautions 'to be followed' the 'Standard of Care' which needs to be taken:
Special warnings and 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."
37. It was vehemently argued by the Learned Counsel for the Hospital that the administration was indeed monitored as can be seen from the notes of Dr. P.S. Mann. In the consumer medicine information it is stated Actilyseis used for Acute Massive Pulmonary Embolism and that the same should be carefully administered if the patient is suffering from Diabetes Mellitus; had Heparin in the last 48 hours; has abnormal blood glucose level; or has high blood pressure. It is also recommended that for the treatment of Heart Attack or Pulmonary Embolism, Heparin must be given at the same time as that of Actilyse or soon after the treatment of Actilyse, but the two medicines must be given through separate drip lines. As the side effects include low blood pressure, breathlessness, allergic reactions, irregular heartbeat, fever and even a Cardiac Arrest, close monitoring is considered necessary. The treatment record filed by the Hospital does not anywhere state whether the aforementioned precautions were taken.
38. Dr. Sudhir Saxena filed an affidavit stating that the Complainant was referred back to Dr. Jayant Banerji for carrying out scientific investigation to analyze and establish accurate diagnosis of physical disorder. He has categorically stated that the injection Atilyse, allegedly administered at Inscol Hospital on 02.08.2005 to the Complainant was neither given under his supervision nor was he present at that time when the procedure of giving the injection was carried out. It is interesting that Dr. P.S. Mann had filed an affidavit that he is working as a Resident Medical Officer in Inscol Hospital and was on duty on 02.08.2005 and that the injection Actilyse was given under his supervision by Kapil Nayyar (staff nurse). It is pertinent to note that the record is silent about the qualifications and the role played by the said Kapil Nayyar. There was also a letter addressed by the Complainant's husband to Dr. Sudhir Saxena on07.11.2005 seeking clarification with respect to the consultation fee charged by Dr. Sudhir Saxena for treating the Complainant. Even in that reply Dr. Sudhir Saxena reiterated his stand that he had referred the Complainant back to Dr. Jayant Banerjee and that his consultancy was never engaged by Inscol Hospital nor was he paid any charges for the same. In the light of this affidavit, the contention of the Hospital and Dr. Jayant Banerjee that TPA was administered on the advice of Dr. Sudhir Saxena cannot be sustained.
39. The fact remains that the Complainant had gone into septic shock and was admitted in Fortis Hospital on 02.08.2005 and she had remained there till 12.09.2005. She was again admitted on 14.09.2005 with worsening Anuria, increasing Anasarca and Cellulitis in the right thigh. Her condition failed to improve with Furosemide Infusion. Growth of Pseudomonas was detected on pus culture and sensitivity done of the right thigh. She was discharged on 22.09.2005 and referred to PGIMER for superior management.
40. At the cost of repetition, we observe that the treatment record and the case sheet is silent about the monitoring of the administration of TPA; except for stating that it was done under the advice of Dr. Sudhir Saxena, who vehemently denied the same in his affidavit; Dr. P.S. Mann was a duty Doctor at that point of time who admittedly did not have the relevant qualification as prescribed by Medical Council of India to practice in India; the consent letter was counter signed by Dr. P.S. Mann who was not authorised to do so. Under such circumstances, we are of the considered view that Actilyse was not administered under proper supervision. It is pertinent to note that on a pointed query to Dr. P.S. Mann, who was present before us, it was stated that Dr. Jayant Banerjee had written the progress sheet, but had not signed it.
41. It is the Complainant's case that the medical records were not provided to him, it is the primary responsibility of the Hospital to maintain and produce patient's records on demand by the patient. The other contention of the Complainant's husband was that he had only sought for detailed medical diagnosis reports with intervention of the Medical Council of India and that no Complaint was lodged by the Complainant with Punjab Medical Council on the subject of Medical Negligence. A Complaint was filed on 18.10.2005 under rule1.3.2 of Indian Medical Council (professional conduct, etiquette and ethics) Regulation, 2002 which mandates that the medical record should be issued within 72 hours of demand. We find force in the contention of the Complainant that Medical Council of India in turn had unilaterally framed issues of medical negligence and diverted the complaint on 06.12.2005 to Punjab Medical Council, in the absence of any such specific pleading by the Complainant herein. There are no substantial reasons given by Medical Council of India for having converted the complaint of non-furnishing of medical reports to that of medical negligence and diverting it to Punjab Medical Council. It is pertinent to note that admittedly the photo copies of medical record were belatedly provided by the Inscol Hospital on 28.07.2006 against legal notice after a lapse of about 11 months. The legal system relies mainly on documentary evidence in a situation where medical negligence is alleged by the patient or the relatives. Medical records include a variety of documentation of patient's history, clinical findings, diagnostic test results, preoperative care, operation notes, postoperative care, and daily notes of a patient's progress and medications. The issue of medical record keeping has been addressed in the Medical Council of India Regulations 2002 guidelines answering many questions regarding medical records. The important issues that have been addressed are as follows:
Maintain indoor records in a standard Proforma for 3 years from commencement of treatment (Section 1.3.1 and Appendix 3).
Request for medical records by patient or authorized attendant should be acknowledged and documents issued within 72 hours (Section 1.3.2).
Maintain a register of certificates with the full details of medical certificates issued with at least one identification mark of the patient and his signature (Section 1.3.3).
Efforts should be made to computerize medical records for quick retrieval (Section 1.3.4).
Non furnishing of medical records within the stipulated period amounts to deficiency of service for which act, the Hospital is liable.
42. We Acknowledge the fact that Dr. P. S. Mann was a junior doctor who might have acted on the directions of the senior doctors who undertook the treatment of the Complainant in the said Hospital. Though, we are also mindful of the fact that Dr. P.S. Mann did not possess a proper qualification as contemplated under the rules of Medical Council of India, but, since he is a junior doctor whose contribution to the negligence is far less than that of the treating doctor involved, we agree with the finding of the State Commission in exonerating him of any liability. We do not wish to address ourselves to the ruling of the Medical Council of India regarding qualification of Dr. P. S. Mann or otherwise as the case in hand pertains to medical negligence and the Complainant is at liberty to approach the appropriate forum, if so advised.
43. The last contention of the Complainant is that though the Hospital was equipped with ventilators, taking into consideration the serious condition of the Complainant, the ventilator was not made available which necessitated the shifting of the Complainant to Fortis Hospital. We do not find any deficiency of service on behalf of the Hospital with respect to this issue as they have rightly referred the Complainant to a higher management hospital. It may not be possible for the Hospital or the doctors to wean away other patients who are under ventilatory support and provide the same to the Complainant herein.
44. The Hon'ble Supreme court in V. Krishnakumar Vs. State of Tamil Nadu & Ors. (2015) 9scc 388 while quantifying the compensation held as follows:
"The principle of awarding compensation that can be safely relied on is restitutio 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's case (supra), in the following passage from the latter:
"170. Indisputably, grant of compensation involving an accident is within the realm of law of torts. It is based on the principle of restitutio 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 v. Rawyards Coal Co.)."
An application of this principle is 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."
45. The Hon'ble apex court in Balram Prasad Vs. Kunal Saha, (2014) 1 SCC 384 has relied on Smt. Savita Garg Vs. National Heart Institute (2004) 5 SCC 56 and laid down that Hospital is vicariously liable for the acts if its doctors. Therefore the direction given by the State Commission that Hospital shall pay 50% of the amount cannot be viewed as excessive. The State commission has modified the order of the District forum directing Dr. Jayant Banerjee to pay 50% of the amount who is also covered by the Insurance Company and the remaining 50% be paid by the Hospital. The District forum and the State commission have taken into consideration all the expenses incurred by the Complainant and have rightly awarded ₹1,08,858/- towards amount spent in Inscol Hospital, ₹6,91,095 towards expenses incurred in Fortis Hospital and PGIMR and ₹10,00,00 towards compensation for mental agony and physical harassment. We do not find any illegality or infirmity in the orders of the fora below as far as medical expenses and compensation amounts are concerned. However, we observe that the interest @ 18% p.a. awarded from the date of filing of the Complaint i.e. 24.07.2007 is on the higher side. Accordingly the same is reduced to 9% p.a., while confirming the rest of the order of the fora below.
46. In the result, the Revision Petitions are allowed in part modifying only the rate of interest, which is reduced from 18% to 9%, while confirming the rest of the order passed by the fora below. In case the amounts are not paid to the Complainant within four weeks from the date of receipt of this order the same shall carry interest @ 12% p.a. from the date of filing of the Complaint till the date of realization.
......................J D.K. JAIN PRESIDENT ...................... M. SHREESHA MEMBER