Appeared at the time of arguments

Pronounced on:  1^st June  2021

ORDER

PER DR. S. M. KANTIKAR, MEMBER

1. Brief facts of the case are that the daughter of the Complainant, Kumari Akansha Sharma (hereinafter referred to as the “patient”) aged about 23 years was suffering from upper respiratory catarrh, fever, body ache, chills, and passing scanty loose stools for some days. On 25.10.2014 she was admitted in (hereinafter referred to as the ‘Opposite Party No. 1’) and was treated by various doctors but did not show any improvement and her condition further deteriorated. On 28.10.2014, blood report revealed Leukopenia (less WBC) and Dengue NS1 antigen positive. The blood culture report was awaited. On the same day at around 11pm, the patient complained of chills and rigor, but she was conscious. The doctor administered Avil-1 and Dexa-1ml, but no relief. It was alleged that the doctors were experimenting on the patient with different medicines. On 29.10.2014, the patient had high temperature (105^o F), high BP with irrelevant talk. Therefore she was shifted to the ICU. Her respiratory rate was 40/min, temperature became 103^o F and pH was 7.11. At midnight, the patient became restless, agitated and showing abnormal behavior. It was further alleged that the doctor administered injection ‘Midazolam’ without intubation to the patient which caused respiratory depression. The patient became critical, there was no proper monitoring in ICU. The BP was falling, it was 110/70 mm Hg at 3:29am and fallen to 60/40 at around 5:30am. The patient was on ventilator on PRVC mode with 100% O₂. At 5:36am one of the doctors informed that the patient suffered a respiratory arrest at 4:30am. Subsequently, during treatment the patient died at 11:09am due to hypoxia.

2. Being aggrieved by the alleged gross negligence and carelessness of the treating doctors causing death of his daughter, the Complainant filed a Complaint before this Commission and prayed for total compensation of Rs. 5,23,60,000/- from the Opposite Parties under different heads.

DEFENCE:

3.     The Opposite Party No. 1 stated that the patient was first seen in the OPD on 25.10.2014 with vague symptoms of fever, body ache and upper respiratory catarrh for a week. It increased for the last 3 to 4 days. She was admitted in the Opposite Party No. 1 Hospital with high grade fever. The patient was investigated including Dengue, NS1 and malaria antigen tests. By the evening, the reports were available and the patient was diagnosed as the case of acute febrile illness with Dengue, NS1 positive. On 27.10.2014 in the night, the patient started her menstrual period. Therefore, the nurse on duty was instructed to monitor the flow, however, patient was hemodynamically stable. On the next day, the patient had loose motions. The malaria antigen test was repeated, it was negative. On 29.10.2014, the patient was violent and talking irrelevantly, having high grade fever of 105^o and had signs of incontinence. She was shifted to ICU and at 2.00 am, Inj. Midazolam was given and started ante-epileptic drugs. The ABG revealed severe metabolic acidosis and hyperglycemia. Therefore, insulin infusion along with Sodabicarb was started. At about 4.30 a.m., the patient developed respiratory arrest and hypotension. She was immediately intubated and connected to ventilator. The platelet count was 18000, she was critical and with massive vaginal bleed. The urgent gynecologist was called. An emergency Non Contrast CT (NCCT) of head was done to rule out intracranial bleed. It was reported as defused cerebral edema. At 7.30 a.m. the patient developed ventricular tachycardia and code blue was announced, Cardio-Pulmonary Resuscitation (CPR) was started. However, the patient again developed cardiac arrest and declared dead at 11.11 a.m.

ARGUMENTS:

 Argument of the Complainant:

4.     The learned Counsel for the Complainant vehemently argued that due to sheer negligence and carelessness during treatment of the Opposite Parties, the Complainant’s daughter died. The condition of the patient was deteriorated quite before; however after repeated requests from the parents, the patient was shifted very late to the ICU. The patient was not catheterized for urine output and NCCT head was also done after quite delay. The hospital was not well equipped and the staff was careless. Because of delayed intubation and ventilation, the patient died due to hypoxic injury to her brain and respiratory depression due to injection Midazolam. The Complainant filed the following article:

1. Midazolam is more likely to cause hypotension than etomidate in emergency department rapid sequence intubation – Emerg Med J2004 21:700-702 doi: 10.1136/emj.2002.004143

2. Slow injection does not prevent Midazolam – induced ventillatory depression. Anesthesia & Analgesia: February 1992

Argument of the Opposite Parties:

5.     Learned Counsel for the Opposite Party No. 1 vehemently argued that the Columbia Asia Hospital is a multi-specialty hospital. He submitted that immediately after admission of the patient, the blood investigations were called without any delay and treatment was started. The blood investigation CBC, LFT, KBC, malaria antigen and dengue serology were performed. On the same day, blood culture sample was sent. The patient had persistent leucopenia and fever. The urine culture was sterile and the blood culture was awaited. The ECHO was normal. The learned Counsel denied that the medicines were administered on experimental basis and there was lack of monitoring. The patient was seen by team of doctors at regular intervals. The cause of respiratory depression and arrest was not due to administration of injection Midazolam. The injection was given for the patient’s violent behavior and hyperpyrexia induced delirium / seizure. He further submitted that there was a genuine typographical error while recording cardiac activity which could be verified from the entries in the ICU register. Regarding availability of the blood, the learned Counsel submitted that there was no blood bank facility in the hospital, however, there was an understanding with a blood bank which was in close proximity of the hospital. The cause of the death was fever with thrombocytopenia but it was not hypoxic brain injury as alleged by the Complainant or due to delayed treatment or respiratory depression.

6.     The Opposite Parties had provided the best available treatment to the patient to save the life of patient. The Opposite Parties followed standard Medical protocols as prescribed by WHO and there is no negligence on the part of Dr. Ashish Sharma (hereinafter referred to as the ‘Opposite Party No. 2’).

7.     As per the medical literature and articles, Dengue is a very serious illness worldwide. The rate of death in Dengue Cases is around 6%. Dengue carries a lot of complications itself in spite of best treatment worldwide. Happening of such complications is beyond medical expertise. There is no definitive treatment of Dengue. Only treatment available is conservative (means taking such steps to minimize complications and correcting them when they happen). The Opposite Parties have filed the following literature in this regard:

(i)       Comprehensive Guidelines for Prevention and control of Dengue and Dengue Haemorrhagic Fever - Revised and expanded edition, issued by WHO

(ii)      18^th Edition Harrison’s Principles of Internal Medicine – Volume 1

(iii)     Mandell, Douglas, and Bennett’s Principles and Practice of Infectious Diseases, Seventh Edition- Volume 2

(iv)      The New England Journal of Medicine – Critical Care Collection – Issue 1.

The learned Counsel for the Opposite Party No. 2 filed the literature on:

(i)        Guidelines of dengue management by WHO, Chapter 4, 5, 6 & 7 (Annexure-1);

(ii)       Predictors of Dengue-Related Mortality and Disease Severity in a Tertiary Care Center in North India – Dengue Severity and Mortality Predictors. OFID (Annexure-2);

(iii)      Fatal dengue hemorrhagic fever in adults during a dengue epidemic in Singapore – International Journal of Infectious Diseases (2007) 11, 263-267 (Annexure-3)

(iv)       Dengue Fever -  WebMD

(v)        A Clinical Study of the Patients with Dengue Hemorrhagic Fever During the Epidemic of 1996 at Lucknow, India - Vol 30 No. 4 December 1999

(vi)       The Epidemiolgy of Dengue in the Americas Over the Last Three Decades: A worrisome Reality- Am.J. Trop.Med.Hyg.82(1)2010, pp.128-135

(vii)      Fatal dengue hemorrhagic fever in adults during a dengue epidemic in Singapore – International Journal of Infectious Diseases (2007) 11, 263-267

DISCUSSION:

8.     We have gone through the medical literatures on Dengue Shock. Also perused the Harrison's Principles of Internal Medicine, 20^th Edition, and   one article on “Dengue Shock” from J Emerg Trauma Shock 2011 Jan-Mar; 4(1): 120–127. Accordingly, the dengue viruses are transmitted to humans by infected mosquitoes, mainly Aedes aegypti and Aedes albopictus. There are four serotypes of the dengue virus: types 1, 2, 3, and 4. Many infections are asymptomatic. Symptomatic dengue results in two defined syndromes: dengue fever (DF) and DHF/DSS. In 20-30% of dengue haemorrhagic fever cases, the patient develops shock, known as the dengue shock syndrome. Worldwide, children younger than 15 years constitute 90% of dengue haemorrhagic fever patients. The DF is a simple, self-limiting febrile illness, DHF is a severe and potentially life-threatening condition. DHF/DSS is characterized by thrombocytopenia, with the resultant hemorrhagic manifestations; in addition, there is increased vascular permeability, resulting in depleted intravascular volume and shock. Severe, profound shock is a dangerous complication and known to occur in extreme cases and is associated with high mortality. Severe dengue occurs as a result of secondary infection with a different virus serotype. Increased vascular permeability, together with myocardial dysfunction and dehydration, contribute to the development of shock, with resultant multi organ failure. The onset of shock in dengue can be dramatic, and its progression relentless. The pathogenesis of shock in dengue is complex. Diagnosis is largely clinical and is supported by serology and identification of viral material in blood. No specific methods are available to predict outcome and progression.  No specific therapy has yet been proven to be of value, and the mainstay of management continues to be careful fluid resuscitation.  Corticosteroids and intravenous immunoglobulins are of no proven benefit. No specific therapy has been shown to be effective in improving survival.

9.     In the instant case we note that; on 25.10.2014 at 12.52 pm the patient was first seen in OPD and complained vague symptoms of upper respiratory catarrh, fever and body ache for 7 days. She took treatment from outside practitioner and received antibiotics and NSAID etc. As the symptoms worsened for last 3-4 days; she was admitted at the Opposite Party No. 1 hospital and intravenous (IV) fluids and other supportive treatment was started. Blood samples were taken for investigations viz complete blood counts, liver function test, kidney function test, urine routine/microscopic and culture, blood culture, Dengue Serology including dengue NS 1 antigen and malaria antigen. The Chest X ray and USG of whole abdomen were done. The reports were available in the evening and it was diagnosed as Acute febrile illness with dengue NS1 positive status and it was communicated to the patient’s attendants. Thereafter till 28.10.2014, the patient was under close monitoring and treatment. On 29.10.2014 at 1.45am, Dr. Ashok Kumar, Consultant of Internal medicine found that the patient was talking irrelevantly, with violent behavior, high grade fever 105^oF and urinary incontinence. On the advice of the Opposite Party No. 2 the patient was immediately shifted to ICU. Due to serious Dengue fever, the condition of the patient became more critical despite of best efforts from the Opposite Parties. The Midazolam injection was given for violent behavior of patient and it is a standard drug given with utmost care. However, despite of continuous monitoring, ventilator, and Inotropic support, patient developed cardiac arrest and died at 11.11am on 29.10.2014.

10.    The Medical Record and Evidence revealed that the patient suffered high grade fever and after hospitalisation, the doctors (Specialist) immediately examined the patient and carried out the relevant investigations including Dengue NS1 and malaria. Patient showed Dengue NS1 positive and the treatment was started in the ICU as per standard protocol. As per medical literature, no specific treatment was available for dengue syndrome and such patient’s progress to profound shock due to   sudden hypotension. The pathogenesis of dengue shock syndrome (DSS, grade 3 and 4) is not yet completely understood. Several factors are reportedly associated with DSS, a more severe form of dengue infection that reportedly causes 50 times higher mortality compared to that of dengue patients without DSS.  

11.    In the instant case, we do not find any negligence for administration of injection Midazolam to the patient. It is evident from the Medical Record that the patient was critical, violent and irritable. These were the signs of Dengue Shock. Injection Midazolam is used to prevent anxiety, cause sedation, and amnesia before medical procedures. As per the Medical and Pharmaceutical literature, drug Midazolam belongs to a group of drugs called benzodiazepines, which helps to slow down activity in the central nervous system. Common side effects of midazolam include headache, nausea, and vomiting. Midazolam can also cause dizziness and drowsiness. In the instant case the respiratory depression was because of severity of Dengue-Dengue Shock and not due to injection Midazolam.  The dosage and the administration of Midazolam were monitored. It was not excessive dose also. The patient was properly intubated and given O₂ and ventilator support. We do not find any dereliction in duty of care from the treating doctor.

12.    The Hon’ble Supreme Court in Jacob Mathew’s case clearly held that the doctor faced with emergency ordinarily tries his best to treat the patient for his suffering and thus, he was not acting with negligence or any omission. The Hon’ble Supreme Court in reference to medical negligence in the case of Jacob Mathew Vs. State of Punjab & Anr., 2005 (6) SCC 1, directly applicable in the present case, where it says:

“29.  A medical practitioner faced with an emergency ordinarily tries his best to redeem the patient out of his suffering. He does not gain anything by acting with negligence or by omitting to do an act. Obviously, therefore, it will be for the complainant to clearly make out a case of negligence before a medical practitioner is charged with or proceeded against criminally. A surgeon with shaky hands under fear of legal action cannot perform a successful operation and a quivering physician cannot administer the end-dose of medicine to his patient.

30.   If the hands be trembling with the dangling fear of facing a criminal prosecution in the event of failure for whatever reason\027 whether attributable to himself or not, neither a surgeon can successfully wield his life-saving scalper to perform an essential surgery, nor can a physician successfully administer the life-saving dose of medicine. Discretion being better part of valour, a medical professional would feel better advised to leave a terminal patient to his own fate in the case of emergency where the chance of success may be 10% (or so), rather than taking the risk of making a last ditch effort towards saving the subject and facing a criminal prosecution if his effort fails. Such timidity forced upon a doctor would be a disservice to the society.

  xxxxxx

32.   The subject of negligence in the context of medical profession necessarily calls for treatment with a difference. Several relevant considerations in this regard are found mentioned by Alan Merry and Alexander McCall Smith in their work "Errors, Medicine and the Law" (Cambridge University Press, 2001). There is a marked tendency to look for a human actor to blame for an untoward event \026 a tendency which is closely linked with the desire to punish. Things have gone wrong and, therefore, somebody must be found to answer for it. To draw a distinction between the blameworthy and the blameless, the notion of mens rea has to be elaborately understood. An empirical study would reveal that the background to a mishap is frequently far more complex than may generally be assumed. It can be demonstrated that actual blame for the outcome has to be attributed with great caution. For a medical accident or failure, the responsibility may lie with the medical practitioner and equally it may not. The inadequacies of the system, the specific circumstances of the case, the nature of human psychology itself and sheer chance may have combined to produce a result in which the doctor’s contribution is either relatively or completely blameless. Human body and its working is nothing less than a highly complex machine. Coupled with the complexities of medical science, the scope for misimpressions, misgivings and misplaced allegations against the operator i.e. the doctor, cannot be ruled out. One may have notions of best or ideal practice which are different from the reality of how medical practice is carried on or how in real life the doctor functions. The factors of pressing need and limited resources cannot be ruled out from consideration. Dealing with a case of medical negligence needs a deeper understanding of the practical side of medicine.”

13.    In our considered view, the doctors treated the patient with reasonable standard of care and there was no deficiency or negligence on their part. The Complainants failed to prove any negligence or any deficiency during treatment on the part of the doctors or the hospital.

        The Complaint is dismissed.