Thiopental Administration: Anaesthetist Absolved of Medcial Negligence
New Delhi : In an important case concerning anaesthetists, the National Consumer Disputes Redressal Commission ( NCDRC) was recently seen absolving an anaesthetist of overdose of Thiopental and setting aside the order of the state commission that asked the anaesthetist to pay a fine of Rs 15 lakh for allegedly injecting a patient with excess dose of medicine and causing his death 15...
New Delhi : In an important case concerning anaesthetists, the National Consumer Disputes Redressal Commission ( NCDRC) was recently seen absolving an anaesthetist of overdose of Thiopental and setting aside the order of the state commission that asked the anaesthetist to pay a fine of Rs 15 lakh for allegedly injecting a patient with excess dose of medicine and causing his death 15 years ago.
The incident goes back to 2002, when the deceased patient had consulted Surgeon Dr Rajendiram with complaints of penile pain and dysuria. Post tests he was diagnosed as having VUJ-calculus of 3X2 mm and two large stones in Gall Bladder for which he got admitted at Ashok Nursing home
On the day of the operation He was operated at 1.20 p.m. by induction of general Anesthesia (GA) with 250 mg. of Thiopental and 100 mg. of Scoline. The intubation was resorted, however, the tube could not pass through due to difficult airway, because of large leafy epiglottis and anteriorly placed Larynx. After the first unsuccessful attempt of intubation, again at 2.00 p.m. the petitioner adjusted the head of the patient and second attempt for intubation was made with the injection of Scoline 75 mg, Thiopental 100 mg. and Atropine 0.6 mg. Even the second attempt of intubation was failed. Therefore, the surgery was abandoned. To avoid laryngeal edema, Efcorlin 100 mg, Decadryl 8 mg was given. The patient’s vitals were examined and to maintain ventilation, laryngeal mask airway introduced. The Oxygen Saturation was maintained. SPO2 was at 95%.
At 3.30, the patient was fully recovered from the effect of anesthesia and the patient was shifted to Post Operqation Ward but at 4.00 p.m., the patient developed profound pulmonary edema. Hence, the patient was given Lasix 40 mg, Inj. Efcorlin 100 mg. and nibulisation was done. As the oxygen level was going down to secure the airway, Tracheostomy was performed and pulmonary edema was controlled for a while. The patient developed ST depression, Hypoxemia. NTG patch applied and the cardiologist was called. At 4.20 p.m. ST was 2.9 mm. BP dropped also. There was Bradycardia 36 per minute. The patient was resuscitated that point of time. The patient’s relatives were called and explained about the situation. The cardiologist also examined the patient and advised to continue the same treatment. The resuscitation was done till 6.00 p.m. At 6.15 p.m. the patieint was declared dead.
The post post mortem report of Forensic Medicine stated that the cause of death of the patient was due to Injection of Thiopental. Based on the final report , wife of deceased alongwith her two minor children filed a complaint before the District Consumer Disputes Redressal Forum, Puducherry (in short, ‘the State Commission’) seeking compensation of Rs. 19 Lakh
The doctors challenged the allegations in the district court. Dr. M. Ravishankar, Professor and Head of the Department of Anesthesiology and CCU, JIPMER, Puducherry was examined as an expert witness, who deposed that the Thiopental dose was within normal limit and it was administered correctly and there was no negligence.
The district forum dismissed the complaint, however, the complainants filed an appeal with the Puducherry State Consumer Disputes Redressal Commission (in short, ‘the State Commission’) which partially allowed the appeal only against the petitioner and thereby set aside the order of District Forum. The State Commission directed the petitioner to pay Rs. 15 lakhs alongwith Rs.10,000/- towards costs.
The doctors then challenged the state commission decision before the NCDRC. The petitioner also filed an appeal with the High court alleging negligence, but the high court also dismissed the complaint.
The counsel for the doctors argued that there was no negligence in the administration of anaesthesia.The counsel further submitted that the difficulty in intubation on first attempt is a commonly encountered situation and under acceptable medical norms upto three attempts are allowed. 94.9% intubation could be performed in first attempt, 3.8 % patient a second attempt and in 1 patient third attempt is needed.” In the instant case, after two unsuccessful attempts of intubation, the petitioner decided to abandon the surgery since it was elective surgery.
After going through the arguments, NCDRC upheld the deposition given byDr. T. Venkatachalam, Professor, Dept. of Anesthesia, Madras Medical College & Hospital, Chennai who appeared as an independent court witness for expert opinion,, which stated
After going through the arguments the court observed
On this basis the court concluded that there was no excess dose of Thiopental as alleged, thus setting aside the decision of the state commission .
Attached is the judgement below
Case History
The incident goes back to 2002, when the deceased patient had consulted Surgeon Dr Rajendiram with complaints of penile pain and dysuria. Post tests he was diagnosed as having VUJ-calculus of 3X2 mm and two large stones in Gall Bladder for which he got admitted at Ashok Nursing home
On the day of the operation He was operated at 1.20 p.m. by induction of general Anesthesia (GA) with 250 mg. of Thiopental and 100 mg. of Scoline. The intubation was resorted, however, the tube could not pass through due to difficult airway, because of large leafy epiglottis and anteriorly placed Larynx. After the first unsuccessful attempt of intubation, again at 2.00 p.m. the petitioner adjusted the head of the patient and second attempt for intubation was made with the injection of Scoline 75 mg, Thiopental 100 mg. and Atropine 0.6 mg. Even the second attempt of intubation was failed. Therefore, the surgery was abandoned. To avoid laryngeal edema, Efcorlin 100 mg, Decadryl 8 mg was given. The patient’s vitals were examined and to maintain ventilation, laryngeal mask airway introduced. The Oxygen Saturation was maintained. SPO2 was at 95%.
At 3.30, the patient was fully recovered from the effect of anesthesia and the patient was shifted to Post Operqation Ward but at 4.00 p.m., the patient developed profound pulmonary edema. Hence, the patient was given Lasix 40 mg, Inj. Efcorlin 100 mg. and nibulisation was done. As the oxygen level was going down to secure the airway, Tracheostomy was performed and pulmonary edema was controlled for a while. The patient developed ST depression, Hypoxemia. NTG patch applied and the cardiologist was called. At 4.20 p.m. ST was 2.9 mm. BP dropped also. There was Bradycardia 36 per minute. The patient was resuscitated that point of time. The patient’s relatives were called and explained about the situation. The cardiologist also examined the patient and advised to continue the same treatment. The resuscitation was done till 6.00 p.m. At 6.15 p.m. the patieint was declared dead.
The post post mortem report of Forensic Medicine stated that the cause of death of the patient was due to Injection of Thiopental. Based on the final report , wife of deceased alongwith her two minor children filed a complaint before the District Consumer Disputes Redressal Forum, Puducherry (in short, ‘the State Commission’) seeking compensation of Rs. 19 Lakh
Lower Commission Decisions:
The doctors challenged the allegations in the district court. Dr. M. Ravishankar, Professor and Head of the Department of Anesthesiology and CCU, JIPMER, Puducherry was examined as an expert witness, who deposed that the Thiopental dose was within normal limit and it was administered correctly and there was no negligence.
The district forum dismissed the complaint, however, the complainants filed an appeal with the Puducherry State Consumer Disputes Redressal Commission (in short, ‘the State Commission’) which partially allowed the appeal only against the petitioner and thereby set aside the order of District Forum. The State Commission directed the petitioner to pay Rs. 15 lakhs alongwith Rs.10,000/- towards costs.
The doctors then challenged the state commission decision before the NCDRC. The petitioner also filed an appeal with the High court alleging negligence, but the high court also dismissed the complaint.
NCDRC Decision
The counsel for the doctors argued that there was no negligence in the administration of anaesthesia.The counsel further submitted that the difficulty in intubation on first attempt is a commonly encountered situation and under acceptable medical norms upto three attempts are allowed. 94.9% intubation could be performed in first attempt, 3.8 % patient a second attempt and in 1 patient third attempt is needed.” In the instant case, after two unsuccessful attempts of intubation, the petitioner decided to abandon the surgery since it was elective surgery.
After going through the arguments, NCDRC upheld the deposition given byDr. T. Venkatachalam, Professor, Dept. of Anesthesia, Madras Medical College & Hospital, Chennai who appeared as an independent court witness for expert opinion,, which stated
in the case on hand, 14.5 micro grams/ml of thiopental was found which according to me is well within the possible level of drug to be administered to produce anesthesia. Going by the level of thiopental found in the blood of deceased in this case, I am sure that 143.5 micro grams of thiopental fond in the blood of the deceased would not have caused the death at all. I differ from the opinion offered form the doctor who had given opinion and conducted post mortem, in respect of cause of death. In my definite opinion, the cause of death in this case surely was not due to the presence of 14.5 micro grams of thiopental/ml of blood. According to him, thiopental was not the cause of death in the patient. It is pertinent to note that ext. 3 chemical analyst opinion that there was 14.5 microgram of thiopental present in the blood. It was not excess dose.
After going through the arguments the court observed
We have noted that the State Commission accepted the expert evidence of Dr. T. Venkatachalam and held that drug was not the cause of death. However, in our view, it is an erroneous finding recorded by the State Commission. The main question remains here is whether Thiopental was the cause of death. Because the consumer compliant was filed on the basis of final report, which has suggested the cause of death as inj. Thiopental. The cross examination of the doctor, who issued the report categorically admitted that Thiopental is most widely used drug since 1940. He had given the opinion based on the findings of post mortem report. He himself was not an anesthetist. We also find that the tracheotomy was done after 4.00 p.m. when the patient was deteriorating. Both the fora categorically held that the death was not due to Thiopental and the said finding was not challenged, thus, has attained finality. Even the chemical examination report indicates the Thiopental level of 14.5 mcg was within the normal limit. The intubation process was duly monitored and failed intubation did not make pulmonary edema when the patient was fully recovered 14.00 p.m.
On this basis the court concluded that there was no excess dose of Thiopental as alleged, thus setting aside the decision of the state commission .
Attached is the judgement below
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