DR. S. M. KANTIKAR, MEMBER
“It is important when administering any potentially harmful medication that contraindications have been reviewed and don't exist. Therefore, a Hospital that fails to follow, or has an employee breach, the recommended standards of care set out by the drug formulation faces increased chances for being held liable by a court. The patient, who suffered has the greatest chance of succeeding on a claim for negligence”.
1. This order shall decide above-said two appeals. For the convenience, facts are drawn from First Appeal No. 522 of 2013, and the parties are placed to its original position as in the complaint.
2. The brief facts relevant to dispose of these appeals are that the complainant, Shri Sitaram Srivastava’s wife, Smt. Krishna Devi, since deceased, (herein after referred as the patient) suffering from vitiligo skin disease, approached Dr. S. C. Aggarwal, a Skin specialist of Kanpur in January, 1998. Dr. Aggarwal treated her by drug ‘Levamisole 150 mg’. It is alleged that said drug was not meant for treatment of Vitiligo and over dose of said medicine developed nausea, vomiting, pain in abdomen etc. The patient discontinued the treatment on 18.2.1998. On 21.2.1998, the patient consulted Dr. A. K. Trivedi, M. D. (Medicine), D. M. (Cardiology), Heart Specialist, who opined that administration of Levamisole was very wrong prescription. He referred the patient to Dr. R. N. Dwivedi, Senior Physician and Professor of Medicines, G.S.V.M., Medical College, Kanpur. On 25.2.1998, Dr. R. N. Dwivedi suggested immediate shifting of said patient to Sanjay Gandhi Post Graduate Medical Sciences, Lucknow (hereinafter referred as ‘SGPGI’). Accordingly, the patient was admitted on 27.2.1998 in the morning and continued with the treatment till 8.3.1998. It is alleged that on 8.3.1998, patient was given ‘Vencomycin injection’ in a single bolus dose without any IV drip. It instantaneously caused the death of the patient within 10 minutes. ‘Vencomycin’ injection should have been administered slowly through the drip intravenously for more than one hour through the Burette Set. The patient was collapsed. The nurse, who administered the said injection, did not tell the reason of patient’s collapse. By the time, medical officer approached the patient, the patient succumbed to death. The complainant filed a complaint before U.P. State Commission, Lucknow for the alleged medical negligence causing death of his wife.
3. After considering the pleadings and evidence, the State Commission allowed the complaint and granted compensation of Rs.15,65,000/- to be paid by OP within two months, failing which, it shall be liable to pay interest @ 10% per annum from the date of order till its realization.
4. Aggrieved by the impugned order, both the parties filed two cross appeals before this Commission i.e. F.A. No. 522 of 2013 is filed by OP for dismissal of complaint whereas F.A. No. 447 of 2014 is filed by complainant for enhancement of compensation.
5. The arguments were heard. The complainant in person argued the matter and learned counsel for OP Mr. Somiran Sharma argued on behalf of OP.
6. In both the appeals, the parties filed applications for condonation of delay. There is a delay of six days in the FA No. 522 of 2013 filed by the OP. The short delay is condoned for the reasons stated in the application for condonation of delay. The another appeal No. 447 of 2014 filed by the complainant is after the delay of 410 days. He stated the reason in the application for condonation of delay, which is reproduced as under:
‘the present accompanying appeal alongwith the application for condonation of delay on the part of the appellant who is not conversant with legal procedures on affidavit is, therefore, filed for the legitimate additional and enhanced compensation as submitted therein duly supported by the decisions of the Hon’ble Supreme Court. The condonation of delay, if any, on technical grounds, occurred due to ignorance of due process under judicial system which was beyond the control of the complainant and was not intentional and willful may very kindly be condoned. Therefore, the delay in filing the accompanying appeal is liable to be condoned in the interest of justice’.
The complainant stated that he was making efforts to search out Kunal Saha’s case 2014 (1) SCC 384 of Hon’ble Supreme Court dated 24.10.2013. He himself was not an advocate, it took considerable time to procure the said judgment and go through it. The judgment was needed as a reference in the instant appeal for enhancement of compensation. We do not find any reason to condone the delay of 410 days in filing first appeal by the complainant. It is pertinent to note that Kunal Saha’s case was decided on 24.10.2013 by Hon’ble Supreme Court but the instant complaint filed by the complainant was decided by State Commission on 16.5.2013 and the complainant received the copy of the order of State Commission on 6.6.2013. Thus, the first appeal should have been filed within 7.7.2013 i.e. prior to Kunal Saha’s judgment. Therefore, the complainant’s submission on delay is untenable.
7. On merit, the complainant argued himself. He submitted that patient was admitted in SGPGI/ OP. He submitted that on 8.3.1998, staff prepared the Vancomycin injection and injected through the central line as a bolus dose. The complainant argued that, on 8.3.1998, the 2nd dose was to be administered at 4 PM, but the nursing attendant came to administer the said injection at about 4.25 PM and prepared it in 5 ml syringe and infused the entire injection within few seconds directly through the catheter of central line. There was no drip flowing at that time. Thereafter, patient collapsed within 10 minutes and no one was available at that time. The OP falsely prepared the medical record after the incident; it had several interpolations in the timings and administration of dose. It should be infused in 100 ml for more than one hour. After rapid direct administration of VANCOMYCIN Injection within seconds patient complained about sinking of heart, suffocation and fading of breath. After a minute or two, she passed urine, and she became more restless, and collapsed in his hand. This all happened in the very presence of the said nursing attendant of OP, who quickly, escaped from the room, no doctor or staff available nearby. It was shear negligence of nursing attendant, causing the death of complainant’s wife/patient.
8. The learned counsel for OPs vehemently argued that on 27.2.1998, the patient was admitted in SGPGI, diagnosed as suffering from DRUG-INDUCED AGRANULOCYTOSIS due to LEVAMISOLE prescribed by Dr. S. C. Agrawal. It led to suppression of Bone Marrow and caused ‘APLASTIC ANEMIA’. Thus, if Dr. S. C. Agrawal would have taken a slight care, the patient could have saved from developing AGRANULOCYTOSIS. 9. The counsel for the appellant/OP vehemently denied that injection ‘Vancomycin’ was given as a bolus dose. He brought our attention to the nursing record from 5.3.1998 to 8.3.1998. It revealed that on 6.3.98 the injection Vancomycin 500 mg in 100 ml, was to be given 8 hourly, it was further instructed that to infuse the said medicine in more than one hour by controlled pump/burette set through Central Line. Everything was normal and patient showed recovery up to 7.3.98. But, on Sunday the 8.3.1998, due to non availability of the said VANCOMYCIN injection which was to be given at 6 AM was given at 09 AM through Central Line through burette set for one hour. Thereafter the second dose was to be administered at 4 PM by same method. The complainant had wrongly stated that the ‘injection’ was given directly as a single shot in the IV. The nursing staff had given another injection Factum directly through IV whereas ‘Vancomycin’ was given through drip after dilution. The drip was started at 4.00 PM, which was continued for one hour. It is further submitted that, the attending nurse Mr. Ajay Kumar is duly qualified and certified nurse competent to infuse Vancomycin on patient. The said nurse had four year experience with SGPGI. In the present case, the same nurse administered ‘Vancomycin’ to the patient daily. Ajay Kumar has categorically denied injecting Vancomycin given as bolus. The State Commission ignored the evidence of nurse Ajay Kumar in this case.
10. The counsel for OP further contended that, the Senior Resident doctor noticed the post infusion symptoms. The death of the patient was not due to rapid infusion of injection VANCOMYCIN as alleged. Vancomycin if administered rapidly may develop “RED MAN SYNDROME” i.e. patient would have anaphylacloid reactions including hypotension, wheezing dyspnoea, urticaria or prutitus and may also lead to flushing of upper body, red rashes neck. Nothing was noticed in the present case. The patient died due to sudden Cardiac Arrest.
11. We have perused the medical record, the nursing and progress sheets of SGPGI. It is pertinent to note that, the only allegation of complainant is that, the sudden death of his wife was occurred because of rapidly administrating ‘Vancomycin injection’ without IV infusion through drip at least 1 hour. In contrary, as per OP and the medical record, death was due to sudden cardiac arrest.
12. Thus, we need to find out whether ‘Vancomycin’ injection was administered to the patient rapidly as single bolus dose or through IV drip for 1 hour ? After careful perusal of medical record, the evidence, interrogatories on the file, the death of patient occurred at about 4.35 PM. The evidence of the nurse, Mr. Ajay Kumar is vital in the instant case. He had stated that, he prepared the Vancomycin injection with 5 ml dilution and administered it through the IV drip line; it was run for 1 hour till 5 PM in his presence. But, it is quite surprising to note that, the hospital declared patient died at 4.35 PM. Nothing is mentioned in the affidavit of Ajay Kumar about the patient’s cardiac arrest/death. It is also, not to be ignored that, the nursing sheet showed over writing/ interpolation on 8.3.1998, regarding timings of injection as “2 or 4 or 9”. We are rather surprised that the medical record is devoid of clinical findings pertaining to cardiac arrest and which resuscitation steps were taken by attending or resident doctors.
13. It is important when administering any potentially harmful medication that contraindications have been reviewed and don't exist. We have gone through text book on Internal Medicine ( Harrison) and medical literature on the Vancomycin Toxicity. It revealed that, Vancomycin should be infused slowly in a dilute solution (2.5 to 5.0 g/l) at a rate no greater than 10 mg/min and over a period not less than 60 minutes to avoid rapid infusion-related reactions. Stopping the infusion usually results in a prompt cessation of these reactions. The infusion-related events are seen during or soon after Rapid bolus administration (i.e. over several minutes) may be associated with severe hypotension (including shock and rare cardiac arrest), histamine like responses and maculopapular or erythematous rash (“red man's syndrome” or “red neck syndrome”).
14. The OP/hospital was once able to escape liability in medical negligence and vicarious liability cases if it could show that it was following the standard of care ; however, that defense is inadequate in the instant case, since the guidelines for best practices were not followed by OP. The hospital will only escape liability if: (1) the patient does not prove the appropriate standard of care; (2) the hospital and its employees exercised reasonable care in preventing the patient's injury; (3) the conduct of the hospital or its employees was not the proximate cause of the patient's injury; (4) no inference of negligence was available under res ipsa loquitur; and (5) in an action based on vicarious liability, it was not shown that the allegedly negligent caregiver was the agent of the hospital. Therefore, a Hospital that fails to follow, or has an employee breach, the recommended standards of care set out by the drug formulation faces increased chances for being held liable by a court. The patient, who suffered has the greatest chance of succeeding
on a claim for negligence.
15. On the basis of foregoing discussion, we do not find any reason to enhance the compensation because the State Commission passed the well-reasoned order and awarded just and proper compensation to the complainant. We are of the considered view that the OP is liable for medical negligence in this case. The OP had tried to hush up the matter, failed to maintain medical record properly as per standard of practice. Therefore, we are not inclined to interfere in the impugned order of State Commission. Accordingly, both the appeals are dismissed. The parties are left to bear their own costs.