APPEARED AT THE TIME OF ARGUMENTS              

PRONOUNCED ON: 9^th February 2021

ORDER

PER DR. S. M. KANTIKAR, MEMBER

          The instant Consumer Complaint has been filed by Vinod Kumar Dhanda, the Complainant under Section 21(a)(i) of the Consumer Protection Act, 1986 for alleged medical negligence causing death of his mother during treatment at Batra Hospital and Medical Research Centre, New Delhi (hereinafter referred to as the “Batra Hospital – the Opposite Party No. 1”) and the treating doctor – Dr. Vipul Sud, Surgeon (hereinafter referred to as the Opposite Party No. 2), who was the Medical Director of the Opposite Party No. 1 Hospital and Senior Consultant Plastic Surgeon. (In the Memo of Parties, the Complainant has made Dr. Vipul Sud as Opposite Parties Nos. 2 and 3 for different addresses. However, for convenience we refer Dr. Vipul Sud as the Opposite Party No. 2.)

2.      The brief facts are that the Complainant’s mother Smt. Balwant Rani Dhanda (hereinafter referred to as the “patient”) developed a Sacral bedsore and consulted Dr. Vipul Sud, the Opposite Party No. 2 at the Opposite Party No. 1 Hospital, who advised debridement surgery. He assured that the surgery would be in single setup and the patient would be discharged within five days. The patient got admitted in the Opposite Party No. 1 Hospital on 24.11.2012 and on the same day and again on 27.11.2012 got operated by the Opposite Party No. 2. Unfortunately, on 28.11.2012 in the early morning, the patient passed away. It was alleged that the Opposite Party No. 2 treated the patient casually and failed to provide standard care in the Hospital. The Cardiologist clearance was not taken before both the surgeries. According to the Complainant, at the time of admission, the patient disclosed that she was allergic to Ofloxacin, but from the date of admission, Ofloxacin was administered in the hospital on multiple occasions. The patient also disclosed her past history of Atrial Fibrillation (hereinafter referred to as the “AF”) and thromboembolism, for the same she was taking drug Dilezem 120 mg and Acitrom 1mg (blood thinner) once a day as prescribed by her Cardiologist. It was alleged that the dose of Dilazim was reduced to 30 mg twice daily, therefore, AF worsened during both the successive surgeries. The patient became unstable and her pulse rate was 150 / min, but the treating doctor did not give medicine Cordarone 100mg to reduce the pulse rate below 100 / min. It was further alleged that after the 2^nd surgery on 27.11.2012 anticoagulant Acitrom 1 mg was not administered and PT/INR was not checked regularly, therefore the patient developed bluish discoloration of toes. Despite knowing that it was a sign of thromboembolism, the Opposite Party No. 2 failed to seek an opinion from the Vascular Specialist but called the Cardiac Surgeon, who prescribed Tab. Pletoz 100 mg. It was alleged that though Dr. R. K. Himthani, the Gastroenterologist prescribed injection Lesuride 25 mg three times a day from 26.11.2012, the same was not given. It was further alleged that during 2^nd surgery the Ryle’s tube was inserted without consent and the position of Ryle’s tube, whether it was in stomach or lung, was not confirmed either by aspiration of gastric contents or by X-ray examination. After insertion of Ryle’s tube, the patient became unresponsive and it was conveyed to the duty nurse, but the doctor came after 20 minutes. By that time, the patient was already cyanosed and CPR was started. There was no monitoring equipment in the room. The patient was declared dead at 3.15 a.m. due to cardio-respiratory arrest on 28.11.2012, but Complainant alleged that the patient might have died much earlier. It was further alleged that the Opposite Party No. 2 assured that it was a simple debridement procedure under sedation and guaranteed the complete healing of the sacral bedsore, but in contrary, the patient died due to gross deficiency in service and medical negligence of the Opposite Parties. Being aggrieved, the Complainant filed the Consumer Complaint and prayed compensation for Rs. 15 Crores from the Opposite Parties along with the cost.

3.      The Opposite Parties Nos. 1 to 3 have filed their respective replies and the evidence by the way of affidavits. The Opposite Parties raised preliminary objection on the maintainability of the Complaint for want of pecuniary jurisdiction. Though the Complainant paid Rs. 69,195/- for the treatment, but seeking Rs. 75 lakh towards punitive damages and Rs. 75 lakh for mental agony. The claim was highly exaggerated to bring the Complaint within the pecuniary jurisdiction of this Commission and the Complaint was frivolous and without cause of action. The Opposite Parties denied any negligence or any deviation from the standard medical practice.  At the time of admission, bedsore on sacral region noted with slough and sero-purulent discharge and the patient’s nutrition was poor. The pulse rate was 100 / min, O₂ saturation was 96%. As the patient had previous history of Coronary Artery Disease (CAD) the transfusion of more IV fluids was contraindicated. Such patient needs a high protein and high caloric diet for the recovery from infected bedsore. Therefore, nasogastric feeding through Ryle’s tube was advised. Care was taken to feed the patient in upright position. The consent for medical treatment and anaesthesia was on record, and it was implied for any procedure during the treatment. Therefore separate consent for Ryle’s tube insertion was not taken. The Ryle’s tube was inserted by an Anaesthetist and he confirmed proper placement of tube. The entire surgery was done under sedation and the devitalized (dead) tissue from the bedsore was removed, all bleeding points were secured and the dressing was done.

Arguments on behalf of the Complainant:

4.      The learned Counsel for the Complainant reiterated the facts. He   argued that the patient received fragmented and casual treatment at the Opposite Party No. 1 Hospital. The patient was allergic to Ofloxacin, but same was prescribed to her. The Complainant was asked to sign the General Consent form without any explanation or information. The patient was on IV lines; therefore, there was no need for insertion of Ryle’s tube (nasogastric feeding tube). On 27.11.2012 the Ryle’s tube was inserted without   informed consent.   The doctors did take X-ray to confirm position of RT whether it was in the stomach or in the lung. The learned Counsel brought our attention to the text from Schwartz’s Principles of Surgery, 9^th edition as reproduced as below:

“Blind insertion of nasogastric feeding tubes is fraught with misplacement, and air instillation with auscultation is inaccurate for ascertaining proper positioning. Radiographic confirmation is usually required to verify the position of the nasogastric feeding tube.”

Therefore, it was wrong presumption of doctors that RT was correctly placed. The stomach (gastric) aspirate in the RT was ‘Nil’, it raised the suspicion of insertion of RT in the endotracheal (wind pipe). It was gross negligence.

5.      The learned Counsel further submitted that on several occasions, consultation of Cardiologist was advised but no Cardiologist examined the patient. The patient was taking the drug Dilzem 120 mg (once daily) for Atrial Fibrillation and Tab Acitrom 1 mg once daily for her past history of Deep Vein Thrombosis (DVT). On 26.11.2012, despite worsening of AF, the drug Dilzem was not given till afternoon but only half dosage i.e. Dilzem 30 mg (twice daily) was prescribed. On the next day i.e. 27.11.2012, in the evening, appropriate dose of Dilzem 120 mg (once daily) was prescribed. The instant patient was at high risk of stroke because of clot formation but Acitrom 1 mg was not given to prevent clot formation and failed to do PT/INR tests. The bluish discolouration of patient’s  toes  was a clear sign of cardio-embolism in the case of worsening Atrial Fibrillation and also there was past history of thromboembolism, but the treating doctors failed to administer proper anticoagulant. Instead of that on 26.11.2012 the cardiac surgeon prescribed an antiplatelet drug Pletoz 100 mg in response to the bluish discolouration of toes, however, the use of Pletoz was contraindicated in AF with thromboembolism.

6.      On 27.11.2012, after the 2^nd surgery despite patient’s worsening condition, after 6 p.m. her vitals were not monitored. The medical notes were made in advance without actually checking discolouration of toes. In the progress notes on 28.11.2012, it was mentioned that patient slept comfortably till 6 a.m. and the staff handed over her duty at 8 a.m. However, the patient had already died at 3:15 a.m. Thus, it proves that the record was manipulated at convenience of the Opposite Parties. The doctors initiated CPR measures after much delay. The patient was left to the mercy of her fate in a hospital which was claimed to be one of the best in the capital of the country.

Learned Counsel for Complainant relied upon the following medical literature:

• “European Society of Cardiology Guidelines, 2016” Paulus Kirchhof et. al.
• “Managing Atrial Fibrillation in Elderly Patient: Challenges and Solutions” Nikolaos Karamichalakis et. al.
• “Supplement to Journal of the Association of the Physicians of India”, 1^st June 2014, Vol. 62
• “Management of Acute Atrial Fibrillation” KK Narayanan Namboodiri
• “Atrial Fibrillation-Advances in Treatment” Vol. 20
• “Management of the Older Person with Atrial Fibrillation” Wubert S. Aronow The Journals of Gerontology Vol. 57, Issue 6
• “Cardioembolic Stroke: Everything has changed” J. David Spence (2018)
• “Acenocoumarol: A Review of Anticoagulant Efficacy and Safety” Abhijit Trailokya et. al.

Arguments on behalf of the Opposite Parties:

7.      The learned Counsel for the Opposite Parties argued on following points: 

(i)      Insertion of Ryle’s tube was justified which never caused cardiac arrest.

The instant patient with previous history of CAD, therefore administration of volumes of IV fluids was avoided. Therefore, RT feeding was decided and it was inserted and its placement was confirmed by the anaesthetist. For proper recovery, the patient should be given nutrition having high calorific protein diet. Therefore, nasogastric feeding through Ryle’s tube was started, initially it was slow and then the feeding increased. The RT feeding was done in upright position. Any bed sore or infection cannot be treated unless the patient gets proper nutrition. Though, separate consent was not taken, but consent for medical treatment and for anaesthesia was on record.

(ii)     The bedsore was treated in two stages.

The learned Counsel for the Opposite Party further argued that the patient had sacral bed sore (Grade 2) and it needs treatment with debridement and flap coverage. It could be done in a single stage if the sore was non-infective. However, in the instant case the bed sore was infected therefore two minor surgeries performed. The interval between the surgeries may vary from 2 days to several weeks depending on the condition of the sore and cultures from the wound. It was discussed with the attendant in detail before the patient was admitted for debridement. During the first surgery, all dead and devitalized tissue was removed, all bleeding points were secured and dressing was done. There was seropurulent discharge noted, therefore closure of wound was delayed it was duly informed to the patient’s attendants.

 (iii)   Regarding cardiac care of  the patient

On 26.11.2012, as the patient was not taking orally, the physician and gastroenterologist examined her. An ECG and other tests were performed. The patient’s discharge summary from PSRI did not show significant findings or advice of medicine Dilzem. The Physician after reading the ECG advised Tab. Dilzem 30 mg twice daily. It was a standard dose and it was increased subsequently. The patient was noticed to have bluish discoloration of toes and was slightly cold. In the same evening the patient was seen by Dr. S.K. Pandey, Cardiovascular Surgeon, who was competent in cardiac and peripheral vascular surgeries. For the past 3 years, Dr. Pandey had performed several such surgeries in association with the Opposite Party No. 2. As per the  progress notes Dorsalispedis  artery (artery supplying the foot) was palpable in the affected foot & Doppler study showed normal flow pattern in femoral artery, superficial femoral artery and distal arteries. Therefore no immediate vascular intervention was advised. Therefore, Dr. Pandey added Tab. Pletoz 100 mg BD. On 27^th morning patient was reviewed by Cardiology resident & patient received Tab. Acitrom 1 mg & Dilzem 30 mg. The dosage of Dilzem was further increased to 120 mg on the advice of Cardiologist.  After the surgery the patient’s heart rate was 50 / min and at 5:15 p.m. anaesthetist advised to shift the patient to ward & referred for Cardiologist opinion. Thereafter at 6:00 p.m., patient was seen by the Opposite Party No. 2 and  found to be comfortable & settled with a pulse rate below 100/min. The patient’s attendants were advised Ryle’s tube feeding and also further investigations for atrial fibrillation. The patient was also referred to Dr. Rajiv Bajaj, Senior Cardiologist.  

That the patient’s allergy to Ofloxacin was noted on the first day itself i.e. 23^rd night at 12 p.m. by the resident and conveyed to the consultant the next morning. The only time, patient was prescribed Ofloxacin was on 27^th evening post operatively i.e. around 5 pm. However, it was noted by the Opposite Party No. 2 Dr. Vipul Sud within an hour and was struck off before any dose was given.

Learned Counsel for the Opposite Parties has relied on the following medical literature:

• < >< >Kusum Sharma v. Batra Hospital & Medical Research Centre, Civil Appeal No. 1385 of 2001

• Dr. Harkanwaljit Singh Saini v. Gurbax Singh & The National Insurance Company Ltd., 2005 CONSUMER 8674 (NS)

• Santosh Bai Badkul v. Dr. K.L. Bandi & Ors., III (2007) CPJ 177 (NC)

• Sarwat Ali Khan v. Prof. (Dr.) R. Gogi & Ors., III (2007) CPJ 179 (NC)

• Govind Bhimrao Kulkarni v. Mormugao Port Trust Hospital, II (2018) CPJ 80 (NC)

• Girishchandra V. Bhatt & Ors. v. Sterling Hospital, III (2018) CPJ 178 (NC)

• DLF Universal Ltd. v. Tarun Aggarwal, III (2018) CPJ 184 (NC)

• Ravindra Dnyaneshwar Patil & Anr. v. Dr. Vinay Tule, I (2018) CPJ 232 (NC)

• Martin F. D’souza v. Mohd. Ishfaq, I (2009) CPJ 32 (SC)

   

  Findings and Discussion:

  8.      We have perused the entire material on record inter alia the treatment record of different hospitals wherein the patient took the treatment. We have perused the medical literature filed by both sides. The case of the Complainant was that his mother – the patient died in the Opposite Party No. 1 Hospital due to failure of proper treatment of Atrial Fibrillation prior to the debridement of bedsore surgery.  There was no proper consultation amongst the doctors, the doses of crucial medicines were not given and RT insertion was done without the informed consent.

  9.      We note from the medical record that the 87 years old female patient was admitted in the Opposite Party Hospital for treatment of infected bedsore. In the past, she was treated for her multiple health ailments like arterial thromboembolism, constipation, malnourished state and loss of appetite, intestinal motility disorder, hiatus hernia and weakness and dementia. She also suffered from collapsed vertebra with generalized osteopenia and diverticulum of 2^nd part of duodenum. She was treated for Atrial Fibrillation up to 05.12.2011 but there is no record that she consulted any Cardiologist and after 05.12.2011 she was taking Dilzem. It is apparent from the record that the patient was admitted in PSRI on 08.10.2012 and discharged on 13.10.2012. Nothing was mentioned in the advice about the medicine Dilzem. She was again admitted on 21.11.2012 to PSRI and discharged on the same day. Even the discharge summary did not show any reference of medicine Dilzem, it means for one week she was not taking Dilzem. Thereafter, on 23.11.2012 she was admitted in Aasholok Nursing Home for one day, wherein she was not given any Dilzem. Thereafter, the patient admitted in the Opposite Party No. 1 Hospital in the midnight of 23^rd / 24^th Nov. 2012. The Physician examined her and ECG was taken, the symptoms of AF were found. The patient, though fully conscious and oriented was not accepting orally. Since for healing of bed sore high protein diet and adequate nutrition was needed. On 26.11.2012, the Physician and gastroenterologist examined the patient and found that the pulse rate was high. The treating doctor advised few investigations, but same were refused by the attendant (Complainant). However, based on Clinical signs, the Physician prescribed Dilzem 30 mg twice daily and from 27.11.2012 morning Dilzem 120 mg once daily.

  10.    We further note that at the time of admission, the patient had bedsore in the Sacral region with sluffing of­­­­­ skin and seropurulent discharge. Her pulse was 100 per minute and O₂ saturation was 96%. As she was a known case of CAD, high doses of IV fluid were not given. Such patients need a high protein diet for recovery; therefore Ryle’s tube feeding was advised. The feeding was done in upright position as recorded in the progress note. There were no side effects of the Ryle’s tube like regurgitation and / or aspiration. The Ryle’s tube could not lead to cardiac arrest and could be explained on following grounds namely:-

  a)         Insertion of Ryle’s tube in the operation theatre is done by anaesthetist using all instrumentation to ensure that the tube has gone into the stomach.

  b)         There are various methods of checking the location of Ryle’s tube:

  i)                    Injecting air into stomach (ii) Checking for air bubbles in the other end of tube by dipping into a bowl of water (iii) Chest X-Ray in upright position.

  The 3^rd instance is generally done when there is doubt in the first two.

  c)         Feeding by Ryle’s tube is done in upright position. Any fluid in lungs will induce a about of coughing and wheezing in a conscious patient who has an intact gag reflex. (The patient was conscious and responding to commands and had an intact gag reflex.

  d)         The feeding had been done at 8 p.m. and the death was discovered at 2.30 a.m. in an aspirated patient, the problem would be noticed within minutes of feeding.

  11.    It is pertinent to note that the Cardiac Surgeon was consulted as soon as the bluish discoloration of the toes noted. The Cardiac Surgeon possesses competency and the vasculature of the organs. He examined the patient and advised treatment accordingly. As the drug Acitrom takes longer onset of action, therefore, Pletoz, an antiplatelet agent was used. It is an accepted practice for any major surgery. The blood thinners were avoided because it may cause uncontrollable oozing of blood.

  12.    Admittedly it was the known case of Atrial Fibrillation, however, the Complainant misconceived about its treatment aspects associated with bedsore in the instant patient. We do not find any deviation of practice by the Opposite Party No. 2, who performed the debridement surgery in two stages for the severely infected sacral bedsore. It is pertinent to note that for prevention of the stroke and other thromboembolic episodes from AF, the treating doctor consulted the Cardiologist / Cardiac Surgeon, who advised proper doses of Dilzem, Acitrom & Pletoz (antiarrhythmic and anticoagulant / anti platelet drug). We further note that the patient developed cardiac arrest, therefore immediately Code blue was announced and Cardiologist attended.  It was documented as per NABH protocols which were strictly followed in the Hospital.  In our view it was the reasonable care at that situation. It was neither deficiency nor dereliction of duty of care from the treating doctor or hospital. We would like to rely upon the recent judgement of Hon’ble Supreme Court in the case S. K. Jhunjhunwala Vs. Dhanwati Kaur and Anr., (2019) 2 SCC 282, wherein it was held that a doctor or surgeon cannot assure that the outcome of any surgery would be beneficial. The Court held that a professional might be held liable for negligence either if they do not possess the requisite skills that they claimed to have, or they don’t exercise the skill which they have.  While referring to the judgements, the Court said that the human body is like a highly complex machine and a doctor could not assure full recovery of a patient.

  13.    Based on the foregoing discussion, in the given facts and relying upon the precedents from the Hon’ble Supreme Court and the entire Evidence adduced before us, it is not feasible to attribute negligence / deficiency on the Opposite Party hospital and doctors; it is difficult to conclusively establish medical negligence / deficiency on the Opposite Party hospital and doctors.

  The Complaint is dismissed.