Mrityunjay Kumar & 2 Ors. vs Pushpanjali Crosslay Hospital & 5 Ors. on 23 August, 2022

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National Consumer Disputes Redressal

Mrityunjay Kumar & 2 Ors. vs Pushpanjali Crosslay Hospital & 5 Ors. on 23 August, 2022

1. The Present Complaint has been filed under section 21 of the Consumer Protection Act, 1986 (for short "the Act") by Mr. Mrityunjay Kumar & 2 Ors. against Pushpanjali Crosslay Hospital, Vaishali Ghaziabad, and 6 Doctors (hereinafter referred to as the 'OPs', seeking compensation for alleged medical negligence on the part of OPs.

2. The facts leading to the present Complaint are that the wife of the Complainant No. 1 - Mrs. Aparna Singh, an Advocate, aged about 33 years, (since deceased, hereinafter referred to as the 'patient') consulted OP-2, Dr. Shubha Saxena - Gynaecologist & Obstetrician for her pregnancy. Her expected date of delivery (EDD) was 22.09.2011. It was alleged that the OP-2 examined her casually. She did not record weight or BP as mandatory. Few tests including an ultrasonography (USG) examination found to be normal. Thereafter, the patient was under regular Antenatal check-up (ANC) under the OP-2 till 09.09.2011. Total 18 OPD/ANC consultations were held. In the month of August, 2011, she was diagnosed as case of 'gestational diabetes'. The OP-2, for the first time, on 06.09.2011, examined the BP and found it was high, therefore, she advised delivery by Lower Segment Caesarian Section (LSCS) before EDD. The OP-2 examined the patient on 09.09.2011, and recorded BP 160/100 mm of Hg in her own hand writing and prescribed injection Betnesol 12 mg IM (steroid).

3. In the morning of 12.09.2011, for elective LSCS, the Complainant No. 1 got his wife admitted in Pushpanjali Crosslay Hospital at Ghaziabad (hereinafter referred to as the 'OP-1 / Hospital'. The patient was taken to the Operation Theatre (OT) around 12:30 p.m. and delivered a female baby at around 1.22 p.m. After delivery, Injection Methergen was given to her. In the OT itself, the patient developed severe hypertension and pulmonary edema and at 4:15 p.m., she was taken to surgical ICU. Thereafter, around 8:00 p.m. she was shifted to Cardiac Intensive Care Unit (CCU). She suffered cardiac arrest at 5:45 a.m. and expired. The hospital gave the cause of death as- "Mild PIH with peri-partum cardiomyopathy, post LSCS with severe LV systolic dysfunction, global LVEF-25 to 30% with acute LVF with pulmonary edema, ventricular tachycardia".

4. It was utter shock to the Complainant No. 1 and the family members due to death of the patient within 20 hours of admission. The patient's husband (Complainant No. 1) took opinion from various experts. All of them have told that it was not a normal death of his wife, but due to gross negligence of treating doctors. Being aggrieved, the Consumer Complaint was filed by the patient's husband Mrityunjay Kumar and her children (son and daughter). Being aggrieved, the Complainants filed this Complaint and prayed compensation of Rs. 6,00,58,948/- and Rs. 1 Crore for mental agony and trauma.

Defense:

The OPs filed their respective Written Versions and denied the allegations of negligence.

5. The Authorized Representative of the Hospital (OP-1) - Ms. Mohita Chandra filed its reply. It was submitted that there was no role of the OP-1 Hospital till 09.09.2011 i.e. admission of the patient for an Elective LSCS. The patient was under ANC follow up at the clinic of OP-2. Subsequently, during hospitalization, the patient was treated as per the advice of OP-2 and attending qualified doctors. She submitted that as per the clinical preoperative analysis the patient had no symptom of decease and therefore no further craniological investigations perform. The preoperative ECHO was not included in standard care of delivery and the patient was asymptomatic, the oxygen saturation levels were monitored intraoperative and ABG is not a part of standard procedure during LSCS of asymptomatic patient below 40 years of age. The medical opinions placed on record by the complainant are incorrect.

6. Dr. Shubha Saxena- Gynaecologist & Obstetrician (OP-2) filed her reply. She admitted that the patient was under her ANC care from 19.01.2011 till 09.09.2011. The LSCS was performed on 12.09.2011 and at about 4.00 a.m. (intervening night of 12/13.09.2011), the condition of the patient worsened. Despite all resuscitative attempts by the team of doctors, the patient could not survive and was declared dead at 05.45 a.m. Thereafter, necessary paper-work and formalities were completed at the Hospital. The OP-2 left the hospital premises shortly after being informed about the patient's demise. She telephonically enquired with the Complainant specifically as to whether he wanted an autopsy (Post Mortem) to be performed, but the Complainant refused it in hand writing. She further submitted that the allegation of failure to detect PIH at early stage of the pregnancy was wholly baseless. At the first time only on 06.09.2011, the patient's high BP was detected and adequate follow-ups were done and she was prescribed labetalol. Further, urinary protein was detected in the first trimester of her pregnancy, which immediately brought under control. In the tests during the second and third trimester, the urinary protein was absent and therefore, there was absolutely no indication of PIH from early pregnancy. The OP-2 took all possible care and effort to ensure that the Patient's safe delivery as per standard procedure. For the death of the patient, no medical negligence could be attributable.

7. Dr. Sanjay Jhingran- Anesthesiologist (OP-3) as a Senior Anesthetist, in his written version, submitted that on the date of LSCS - 12.09.2011, he was present in the OT from 12.45 pm. He had no role in the diagnosis or consultations of the patient prior to delivery. He submitted that the duties of Anesthetist in the hospital, are assigned on a case by case basis and always 4-5 Anesthetists are stationed in the Main OT Complex and also , they remain available on call to any case. On 12.09.2011, he was asked to attend to the Patient as the spinal anesthesia could not be administered by Dr. Archana Aggarwal (OP-4). Thereafter, Dr. Jhingran also attempted to administer spinal anesthesia, but it was unsuccessful. He submitted that successful spinal anaesthesia administration depends upon the constitution of position of the spinal vertebrae. Therefore, in the instant patient general anesthesia (GA) was given, it was not contraindicated. The GA was induced to the patient smoothly after a good pre-oxygenation. The Counsel further argued that after the delivery as a standard procedure IV Syntocinon was administered for uterine contraction, but the uterus failed to contract, as assessed by obstetrician. Therefore, to achieve proper contraction and avoid PPH repeat dose of Syntocinon, Methergine was administered intra-muscularly by ensuring a sustained slow effect of contracting uterus while minimizing its hypertensive effects. He further argued that, the diagnosis of peri-partum Cardiomyopathy was made by the cardiologist based subsequent ECHO done by him. The ECHO showed severe left ventricular systolic dysfunction which is characteristic of peripartum cardiomyopathy, but the hypertensive heart failure is associated with diastolic dysfunction. Further, since mild increase in blood pressure occurred only 3-4 days prior to surgery and it was adequately treated, there was no pre-existing cause of heart failure. The instant case the peri-partum Cardiomyopathy presented itself as acute LVF after reversal of anesthesia. The patient developed ventricular tachycardia subsequently life threatening cardiac dysrhythmia (abnormal rhythm of the heart). There was no deficiency of service or medical negligence.

8. Dr. Archana Agarwal, Anesthesiologist (OP-4) submitted that she was only attending to the Patient from about 12.20 pm to about 1.30 pm. under senior anesthesiologist. On that day, her duty was from 9.00 am to 5.00 pm. Her duty was to interact with a patient immediately before surgery to perform basic pre-anesthetic checkups and analyze the clinical history provided for by the patient, and check the pre-operative, evaluation questionnaire filed by every patient. After the evaluation, the consent form was to be filled by the patient for general or regional anaesthesia. In the present case, she performed her duty till arrival of the senior Anesthetist, Dr. Sanjay Jhingran.

9. Dr. Prakash Chandra Gera, Consultant, Internal Medicine (OP-5) filed his reply. He submitted that he had no role to play in the diagnosis/ consultations of the patient prior to admission. The physicians as such do not play a role in routine pregnancies at the OP-1 Hospital. His role started around 4.15 p.m. on 12.09.2011 personally, and his team was involved with the case from approximately 2.30 pm onwards. The Patient post LSCS, developed pulmonary oedema, a cardiologist's reference was sought. Accordingly, the patient was immediately under the care of cardiology department.

10. Dr. Gaurav Minocha, Senior Consultant, Cardiology (OP-6) in his reply submitted that his role was limited from around 2.45 pm on 12.09.2011. He submitted that the cardiology team was not routinely involved with pregnancy and pregnancy related surgeries. However, in cases of patients who have some history ·of pre-existing heart disease, or some symptoms diagnosed by her Gynaecologist, the cardiology team was alerted to attend. In the instant case, the patient was asymptomatic of cardiac distress and there was no intimation to the cardiology team before LSCS. The hypertension detected during pregnancy alone is not an indicator of systolic heart dysfunction. He relied upon one medical article titled "Clinical Characteristics of Peripartum Cardiomyopathy in the United States" published in the Journal of American College of Cardiology.

Arguments:

11. We have heard the arguments from the learned Counsel for both the sides. Perused the material on record, inter alia, the Medical Record and gave our thoughtful consideration.

Arguments on behalf of the Complainant:

12. The learned Counsel for the Complainant reiterated the facts and chronology of events in the instant case. He submitted that the OP-2 did not follow the standard reasonable care, who did not record regular blood pressure and her weight during her ANC visits. Therefore, the Pregnancy Induced Hypertension (PIH) was missed and remained untreated. It was the cause of heart complication after delivery. The excessive weight gain during pregnancy is associated with Preeclampsia and gestational diabetes. He further submitted that the OPs wrongly diagnosed the patient as having peri-partum cardio myopathy. It was the diagnosis of exclusion and could not have been made in the instant case of pre-existing hypertension. It was probably HELLP syndrome which was never considered by the OPs. Even the anesthetic record shows the act of omission and dereliction of duties. During LSCS the blood pressure was not properly managed and in the instant case, injection Methergine should not have been given, which was known to increase the blood pressure. He relied upon medical literature and the opinions of three experts on record. The learned Counsel argued on the following points:

i) Patient's blood pressure was not measured during ANC visits. As per standard medical protocol, BP should have been recorded every 3-4 weeks throughout pregnancy. It could have diagnosed the serious complication Pregnancy Induced Hypertension (PIH) or Pre-eclamptic Toxaemia (PET), which the patient developed. The BP was recorded for the first time on 06.09.2011, just a week before delivery, and found to be high.

ii) Without indication, she was administered steroids (injection Betnesol) which led to increase BP and also aggravated her Diabetes.

iii)     After LSCS, injection Methergen was given,it is known to increase BP.

 

iv)      The instant case was of elective LSCS and not an emergency. A cardiologist was never consulted before surgery thought  sufficient time was there to for cardiologist assessment by ECG and ECHO.

 

v)       The pre-anesthetic check-up and clearance was given without opinion of Cardiologist without doing ECG or ECHO.

 

vi)      The BP recording by physician and anesthetist showed  variations in the  anesthesia chart.

 

vii)     The pulmonary edema in the OT could have been avoided by timely diagnosis and treatment of hypertension.

 

viii)    Periodic  arterial blood gas (ABG) was not done In the OT & ICU.

 

ix)      The diagnosis of peri-partum cardiomyopathy was doubtful because the  ECHO report suggests that heart was not dilated and cardiac chambers were normal. In any case, it would have been definitely diagnosed by a Cardiologist but such a specialist was never consulted before operation. 

 

 Arguments on behalf of the OPs:

13. The learned Counsel for the OPs reiterated their replies and evidence on record. He submitted that, the credentials of the medical experts were not disclosed, the opinions are not supported by reasons or literature. He submitted the clinical and pre-operative examination of the Patient, there were no symptoms of heart disease, therefore before the LSCS pre-operative ECHO was not for asymptomatic patient. He further argued that no record has been forged or tampered with, and on the contrary, the records of the case pertaining to the treatment of the Patient at the OP-1 were promptly handed over to the Complainant No. 1 upon a request being made in this regard.

14. The learned counsel further argued that intra-operatively the Oxygen Saturation levels were monitored. ABG monitoring inta-operatively is not mandatory in cases of elective surgeries of asymptomatic patients, under the age of 40. However, ABG levels were checked twice subsequent to the LSCS procedure. After LSCS, the Patient was extubated as per standard procedure. The medical opinions placed on record by the Complainant were obtained by placing incorrect information to the experts.

The OPs relied upon the following medical literature / articles:

A. Relating to Weight Gain in Pregnant Women Weight Gain during Pregnancy- Committee Opinion (The American College of Obs. & Gyn).

Ideal weight gain during pregnancy.

Pregnancy Weight Gain.

Appropriate Body-Mass Index for Asian Population and its implications for policy and intervention strategies.

Determining Optimal Weight Gain.

B. Relating to Administration of Antenatal Steroids):

Antenatal Corticosteroids to reduce Neo Natal Morbidity and Mortality.

Guidelines for the use of Antenatal Corticosteroids for fetal Maturation.

Hypertension in pregnancy - The Management of Hypertensive Disorders during pregnancy -Royal College of Obs. & Gyn.

Medical management of severe Pre-Eclampsia in a critical care setting.

William Obstetrics -Edition 23 - (page 719 - Regarding Plasma Uric Acid in Pre- Eclampsia).

C. Treatment protocols adopted by OP-2 Basic Essential Care recommended for all pregnant women (Source: ICOG GCP Guidelines) Anti Natal Care -Basic Essential Care Recommended (Source: British Medical Journal) To download : Use link http://bestpractice.bmj.com/best-practice/monograph/493.html D. For PIH, preeclampsia, eclampsis , peripartum cardiomyopathy and anesthesia :

William's Obstetrics 23rd Stoelting's anesthesia - 5th edition Miller's anesthesia -

Journal of American College of Cardiology.

Extract from Dr Mukul Kapoor - peripartum cardiomyopathy - Year book of Anaesthesia, A Practical Approach to Obstetric Anesthesia - Brenda A. Bucklin, E. Two Protocols compared with treatment actually given by OP-2 in the instant case.

Basic Essential Care recommended for all pregnant women (Source: ICOG GCP Guidelines) Antenatal Care -Basic Essential Care Recommended (Source: British Medical Journal)

15. On the point of anesthesia the learned Counsel for OPs argued that the baby was delivered at 1:22 pm on 12.09.2011 and Syntocinon was administered for uterine contraction as is the standard procedure. However, when the uterus failed to contract, as assessed by obstetrician, after repeat dose of Syntocinon, Methergine was administered intra-muscularly to achieve proper contraction and avoid post-partum hemorrhage (severe bleeding), by ensuring a sustained slow effect of contracting uterus while minimizing its hypertensive effects. He further submitted that the diagnosis of Peripartum Cardiomyopathy was made by the cardiologist on conducting ECHO test performed subsequently, which revealed severe left ventricular systolic dysfunction. But, the hypertensive heart failure is associated with diastolic dysfunction. Further, since mild increase in blood pressure occurred only 3-4 days prior to surgery and it was adequately treated, there was no pre-existing cause of heart failure. The Patient's BP was maintained intra-operatively by titrating the infusion rates of a drug Nitroglycerine (NTG). He further argued that the Complainant wrongly interpreted the three curves of BP recorded in Anesthesia record as the middle curve was for Mean Blood Pressure (BP). As per standards the three curves are, the Upper curve as Systolic BP, middle curve as Heart/Pulse rate (not "mean BP) and the bottom curve for Diastolic BP. During operation the Pulse, SPO₂ and EtCO₂ were continuously monitored using Pulse Oximeter for oxygen and Capnography for CO₂. These monitors were used and the data was recorded. However these measurements are stored automatically in the monitor's internal memory at 5-minute intervals in a tabulated form and all the readings mentioned in the chart. The rounded off BP noting by were made manually after the surgery which had finished at about 2:00 pm. Hence there was bound to be an expected difference in recordings. In any event, BP was never static and it could be expected to fluctuate at different times.

16. With respect to peri-partum cardiomyopathy, the learned Counsel further argued that the patient did not have any history or symptoms of heart disease prior to delivery. It is submitted that the diagnosis of peri-partum Cardiomyopathy is supported by the results in the ECHO test that was subsequently conducted, which showed severe systolic dysfunction and ejection fraction was 25% (less than 45%). ECHO test is not advised as a routine test as a matter of practice, for patients of mild PIH with no other clinical history or symptoms. Furthermore, it is submitted that hypertension detected in pregnancy alone was not an indicator of systolic heart dysfunction. He relied upon medical article titled "Clinical Characteristics of peri-partum Cardiomyopathy in the United States" published in the Journal of American College of Cardiology is relied upon.

Findings and discussion :

17. We have perused the entire medical record and the relevant literature on the subject of peri-partum cardiomyopathy. The operative and anesthetic notes revealed that all the parameters were monitored and they were within acceptable limits. The extubation was performed after reversal of anesthesia with Neostigmine and Glycopyrrolate, as per standard protocol. After extubation, there was fall in saturation of oxygen. Therefore, 100% oxygen with face mask started and the patient was intubated. However, unfortunately, peri-partum cardiomyopathy manifested itself after extubation and the reversal of general anesthesia. Several medical literatures, such cardiomyopathy remain undiagnosed because the patients for the first time present with heart failure without any previous signs or symptoms.

18. As per standard procedure during LSCS intra-operative ABG monitoring was not routinely done and not mandatory. It is pertinent to note that the time of tracheal extubation the Patient's SPO₂ levels were 100% and afterwards SPO₂ levels started to fall despite the administration of 100% oxygen through face mask and assisted ventilation. That the patient was re-intubated in the OT itself and then pink frothy secretions were noticed in the endotracheal tube on which a diagnosis of Pulmonary Edema was made. It was a post-operative event effectively managed in the operation theatre and the patient was shifted to ICU for further expert management.

19. We further note that Methergine is a choice of drug to avoid post-partum hemorrhage (PPH). It has weak vaso-constrictor properties and its intramuscular use, is not associated with any significant rise in blood pressure, therefore, IV administration is contraindicated. In the instant case, after the delivery of newborn, there was no sufficient contraction of uterus, therefore, Syntocinon was administered. However, when Syntocinon failed to achieve good uterine contraction, therefore, Methergine was administered intra-muscularly. Moreover IV Nitroglycerine (a vasodilator) was started with adjusted dose to control the blood pressure. The BP remained stable as per anesthesia record.

20. Admittedly, Dr. Sanjay Jhingran (OP-3) failed to administer spinal anesthesia, therefore, he proceeded to administer GA after a good pre-oxygenation. According to the Indian College of Anesthesiologists (ICA), it was as per accepted norm and procedure of anesthesia practice. It is also evident that the patient was fasting for more than 12 hours, thus GA was not contraindicated. The ICA opined that there was no negligence.

21. The Complainant in his support relied upon three separate expert opinions from Dr. D. K. Rawat, Anesthetist, Dr. V. K. Kadam, (OBG) and Dr. G. S. Vats, Intensivist / Consultant Physician. All the above opinions expressed that there was negligence during pre-operative and post-operative management of the patient. We are not convinced about three opinions, because admittedly the ECHO showed ejection factor 25% which was clearly confirmatory of Cardiomyopathy.

22. We have perused another opinion in support of the OPs from Dr. Radhesh Hegde, the Head of Department of Anaesthesiology and Critical care at Father Muller Medical College, Mangalore. According to him, it was not a case of Hypertensive pulmonary edema, but it was secondary to the underlying peri-partum cardiomyopathy. The peri-partum of postpartum cardiomyopathy (PPCM) is a rare form of cardiac failure that occurs during the last month of pregnancy or up to five months after delivery. There will be enlargement of heart chambers and weakening of muscles, leading to decrease in the ejection fraction. According to American Heart Association the diagnostic criteria for PPCM are:

1. Heart Failure occurring in the last month of pregnancy or within 5 months after delivery.

2. Reduced ejection fraction of the heart of < 45%.

3. No other causes of heart failure with reduced ejection fraction found.

Therefore, it confirms the Cardiomyopathy in the instant case.

23. It was pregnancy induced hypertension, which was under control. The patient had no symptom of any cardiac disease which did not warrant for ECHO test before the delivery (LSCS). The post-delivery cardiomyopathy was confirmed by ECHO - the reduced ejection fraction to less than 25%. We do not find any breach of duty of care from the treating Gynecologist or Anesthetist. Generally, if a doctor does not act in a reasonable manner to prevent foreseeable injuries to the patient, the duty of care is breached. We would like to rely upon the decision of Hon'ble Supreme Court in the case of Dr. Laxman B. Joshi vs Dr. Trimbak B. Godbole & Anr.[1], which laid down certain duties of doctor that: (a) Duty of care in deciding whether to undertake the case (b) Duty of care in deciding what treatment to give, and (c) Duty of care in the administration of that treatment. A breach of any of the above duties may give a cause of action for negligence and the patient may on that basis recover damages from his doctor. The doctor owes certain duty towards the patient and the doctor can decide the method of treatment, which is more suitable for the patient. In the instant case we find he OP-2 failed in the duty of care towards the patient.

24. On the basis of afore discussion, we conclude that the death of patient was not due to any negligence of the treating doctor. The delivery of the child was uneventful, but unfortunately the mother developed peri-partum cardiomyopathy. It is evident from the ECHO that it was acute left ventricular failure and the ejection factor was 25% which was almost fatal. The patient did not die of surgical procedure complications, but it was an unfortunate Cardiomyopathy. The Complainants failed to prove negligence of the OPs, accordingly the Complaint is dismissed.

There shall be no Order as to costs.

[1] AIR 1969 SC 128 ......................J R.K. AGRAWAL PRESIDENT ...................... DR. S.M. KANTIKAR MEMBER ...................... BINOY KUMAR MEMBER

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