Demanding Advance money for treatment is not wrong, but delayed treatment and not following medical ethics is.. : Adv. ROHiT Erande ©

"Demanding Advance money from Patient for Treatment is not wrong"...  , but Doctors held liable to pay Rs.25 lakhs for delayed  treatment and for  rigid adherence to Protocol than Medical Ethics.

An Important Judgement on Cardiac and Neurological complications. 

Adv. ROHiT ERANDE . ©

Case Details :

CONSUMER CASE NO. 38 OF 2010

YASHUMATI DEVI & ANR. V/s. CHRISTIAN MEDICAL COLLEGE, Vellore

BEFORE:  

  HON'BLE DR. S.M. KANTIKAR, PRESIDING MEMBER

  HON'BLE MR. DINESH SINGH,MEMBER

Decided on 11/08/2020.

http://cms.nic.in/ncdrcusersWeb/GetJudgement.do?method=GetJudgement&caseidin=0%2F0%2FCC%2F38%2F2010&dtofhearing=2020-08-11 (The Judgment Link) 

Facts in Short :

1.       On 10.06.2009 one Mr. Raj Ballav Ram, 58, the deceased patient (husband of the Complinanat)  OPD at Christian Medical College, Vellore (for short “CMC / Hospital”- the Opponent). He was known diabetic and hypertensive. Since year 2006, he was suffering off and on pain in his left arm on exertion, walking and/or climbing the stairs. His Treadmill Test (TMT) done elsewhere was positive and he informed the some to the doctors at CMC. The patient got admitted in CMC as a private patient. On next day, after examination, it was diagnosed as a case of Coronary Artery Disease (CAD) [effort angina NYHA class 2].

2.       On the 13.06.2009, Dr. Oomen K. George, the treating doctor advised patient to undergo ‘Coronary Angiogram’ (CAG) test and if needed, Angioplasty be done at the same setting which will be economical. On the same day, the complainants deposited Rs. 1,50,000/- in the hospital. On 14.06.2009, Dr. Oomen K George while conducting the CAG expressed that it would be better for patient to undergo Coronary Arterial By-pass Graft (CABG) surgery instead of angioplasty to avoid multiple stenting. But due to long waiting list, the patient’s CABG was not possible within 15 days and therefore no specific date was fixed for CABG. On 16.06.2009, Dr. Sujit discontinued medicines Ecospirin and Clopidogrel, and started Heparin 5000 units 6 hourly. It was alleged that Heparin was started without any laboratory investigations or monitoring protocol. The Complainant no. 2 i.e. the Son of the Deceased patient, noted some bleeding at the site of insertion of the intravenous needle, it was informed to the nurse, but despite repeated requests the doctors ignored it. 

3. On 17.06.2009 in the morning at 08.30 am the 3rd dose of Heparin injection was given and after about an hour patient showed signs of sudden numbness of his left arm and trouble in walking and/or wearing slippers. Coincidentally there were four doctors including Dr. George Joseph the Head of the Department - Cardiology-I unit saw the patient and confirmed that the patient seems to have suffered a mini stroke and immediate CT Scan to be done, however but Dr. George Joseph did not do stroke evaluation. It was further alleged that around after the delay of  3.5 hrs after the onset of stroke, the patient was transferred to the Thoracic surgery unit in Semi-ICU and the suggested ‘CT Brain-Plain study’, was delayed also till 12.30 PM. 

4. It was further alleged that the staff told the Son  to remit and get a receipt of Rs. 1850/- for the CT Scan, though they have already deposited Rs. 150000/- as an advance. The doctor in thoracic surgery told the complainant that now it became neurology problem and thence the neurology dept. will look after the patient. Due to such condition of patient the CABG was deferred. The Neurosurgeon after seeing brain CT Scan report informed the complainants that as the patient already progressed into coma, nothing more could be done. Finally, doctors suggested the family that they should accept the inevitable event and instead of wasting money allow them to withdraw ventilator support. 

5. It was alleged that on 17.06.2009 the patient suffered stroke in the morning at 08:30 AM, since then the doctors at CMC virtually did nothing till 10.30 PM and after long struggle the patient died on 20.06.2009 at 6.30am.  Being aggrieved the patient’s wife and Son filed the Consumer Complaint against the CMC for the alleged medical  negligence and callousness of the doctors at CMC caused death of the health  man/patient for seeking compensation of Rs. 2,01,44,000/-.

Defense of Doctors and Hospital :

1. It was alleged that the Complainants filed a false complaint and suppressed the true and correct facts. The OP further submitted that the deceased was admitted in CMC on 14.06.2009 and not on 09/10.06.2009.  The patient came to CMC complaining of chest pain since two years on exertion and it was increasing since last two months. 

2. He was known diabetic for the last 11 years and recently detected as a hypertensive. The Angiography revealed a very serious condition of the heart (TVD) and patient was prone to a fatal heart attack. The patient was given urgent medical attention at the CMC. The OP submitted that the patient was informed about the two kinds of treatment available for coronary arteries blockages namely i) Angioplasty- if blockage is not severe and  ii) By-pass Surgery (CABG) - if the blockage is severe.  The patient agreed for CABG. On16.06.2009, the patient was transferred from Cardiology Unit III to the Cardiothoracic Surgery Unit-II for elective CABG. 

3. As the Cardiac  patient,  he was already taking blood thinners Ecosprin and Clopidogrel which had a risk of causing a bleeding, or leak into, inter-alia, the brain, stomach or urine. On the instructions of Dr. Sujith Velayudhan Indira, from 16.06.2009 evening the blood thinners Ecosprin and Clopidogrel were withdrawn and the Heparin injection 5000 units every six hourly started to prevent clotting of blood. The dose of Heparin was calculated on the basis of body weight of the patient (65 kg) and it was the normal dose. It was contended that as per the common practice the consent is not required for administration of Heparin and that in and around Vellore, the doctors prescribe Heparin without obtaining any specific consent from patient. In CMC for all cases the treating doctor decides for Heparin administration, the quantum and frequency determined on the basis of the health condition of the patient, age, and weight, etc. After further complications, the  patient was kept on ventilator support. The GCS (Glasgow Coma Scale/Score) of the patient was dropped further from 19.06.2009. All the brain stem reflexes were lost, thus repeat CT Scan of the brain was difficult to perform. The neuro and cardiothoracic surgeons reviewed the patient, the prognosis was poor and same was explained to the relatives of the patient. However, despite all the efforts the patient passed away on 20.06.2009 at 6.30 AM, before the CABG could be done. There was no negligence or deficiency in service during the treatment of the patient at CMC, Vellore.  

Held :

1. The National Commission after hearing the arguments at length and after going through the case record, medical literature , it formulated the questions of Considerations and answered them as under.

i)      “ There is nothing wrong to demand Advance deposit for CABG” 

But at the same time, demanding Rs.1850/- for CT Scan,  it was observed that, ““Can doctors insist and wait for money (fees) when death is knocking the doors of the patient?”  Obvious answer is recovery of fee can wait - but not the death nor the treatment for trying to save the life.: 

It should be borne in mind that Angioplasty or CABG surgery is expensive procedure, therefore about expenses the patients shall be informed in advance. The OP hospital asked for some deposit and patient deposited Rs.150000/- in advance to CMC. We note the instant patient travelled from another city and might need some time to arrange the funds, thus in our view nothing was wrong to inform the approximate cost of treatment and demand to deposit an advance. Thus the allegation of the complainants is not sustainable that CMC was only concerned with money.  

There was an urgent need for brain CT scan of the patient but it was delayed more than 3 hours for the want of a fresh receipt of Rs. 1850/- towards CT scan charges even though complainants had already deposited 150000/- in advance. Hospital has every right to insist the payment but it was also a prime duty to care the emergency patient. In this regard we would like to rely upon the judgement of this Commission in   Pravat Kumar Mukherjee vs. Ruby General Hospital and Ors, II (2005) CPJ 35 (NC) which saddled Rs.10 lakhs on Doctors and it was observed that 

"This may serve the purpose of bringing about a qualitative change in the attitude of the hospitals of providing service to human beings as human beings. A human touch is necessary; that is their code of conduct; that is their duty and that is what is required to be implemented. In emergency or critical cases, let them discharge their duty/social obligation of rendering service without waiting for fee or for consent"

ii)      Precautions  before administration of Heparin- laboratory tests and informed consent:

The allegations of complainants that the doctors at CMC before administration of Heparin failed to do diagnostic laboratory tests and to take informed consent. However, the different cardiac centres in India follow their different standard protocols as a common practice. Usually prior to the CABG the blood thinners are stopped at least three to five days before surgery. The laboratory test before Heparin administration is not mandatory unless patient has any history or signs bleeding tendency. The instant patient had no such history of bleeding tendency. Thus, in our view, the decision of treating doctor/surgeon to stop blood thinners and start Heparin before CABG cannot be faulted and the son of the deceased, the  Complainant No. 2 signed the General Consent Form. It reads as follows:

“Permission is hereby given for the performance of any diagnostic examination, biopsy, transfusion or operation and for the administration of any anesthetic as may be deemed advisable in the course of this hospital admission”.   

Moreover, Most of the cardiac centres in India don’t do any blood tests and don’t take informed consent prior to administration of Heparin. 

Thus, in the instant case, in our view at that stage the General Consent was a valid consent. Specific consent for administration of Heparin was not needed. It squarely covers the principles laid down by  the Hon’ble Apex Court in the case  Samira Kohli v. Dr. Prabha Manchanda, (2008) 2 SCC 1.   

iii)     Heparin administration - an overdose & failure to monitor : On this Point the Opponents were held liable for Medical Negligence

In the instant case patient was started Heparin 5000 units 6 hourly from the evening of 16.06.2009 and as per the CMC protocol, the (APTT) test is always done to monitor the patient on Heparin.   The  APTT and Platelet Count were carried out at 9.20 am and found that APTT was high- 165 seconds and low Platelet Count -79,000/ cmm. As per the Harrison’s Handbook of Internal Medicine, [17th edition, 2008] (for short ’Harrison’s’)  APTT should not exceed 80 seconds and in the event of any further increase, Heparin should immediately be discontinued. The reduction in platelet count  ( < 100000/cmm) was a clear indication of Heparin Induced Thrombocytopenia (HIT) and  the antidote, Protamine Sulphate  to neutralize the heparin should be given. During administration of an anti-coagulant like Heparin, the reference levels for APTT are as follows:

 When APTT is greater than 100 seconds is risky for the patient and there are chances for spontaneous bleeding.•

 Panic value usually it is considered above 70 seconds.  •

We note that on 17.06.2009 at 8.30 AM the patient suffered  paresthesia of the left side of the body followed by weakness of both the left and upper and lower limbs and right sided deviation of the angle of the mouth. Though the patient despite showing clear signs of a stroke  another dose of Heparin was given to the patient at 11.30 am. The doctors have not taken the corrective steps. 

iv) Timing of CABG:

According to the medical literature the antiplatelet and anticoagulant therapy is a key part of the management of patients undergoing cardiac surgery. Most heart operations depend on cardiopulmonary bypass with systemic heparinisation. Postoperatively, every patient’s thrombotic and hemorrhagic tendency must be carefully managed.

The timing of CABG surgery in a patient on Clopidogrel depends upon two factors (i) Does Clopidogrel increase the bleeding complications and its sequelae? (ii) Does withholding Clopidogrel in these high-risk patients expose to an increase in thrombotic complications prior to surgery

v)   The Nurse’s daily record and doctor’s Clinical findings  : Contradiction  

On 16.6.2009 at 7 pm, the 1st dose of Heparin (5000 u) was given, thereafter every 6 hours further dose was given at 1200 mid night, 6 am and at 11.30 am on 17.6.2009. Nothing was mentioned in the nursing record about APTT monitoring done. Nursing note on 17.6.2009 at 11.30 am recorded as “patient complaint of left side body weakness” and “informed to TS –II doctor.” However, in contrary   the clinical findings recorded in progress record were 

on 17/6: morning noticed to have tingling left side of body.

He developed left side weakness (upper limb and lower limb) which progressively increased over hours.

By afternoon noticed to have right side deviation of mouth ( 9 am to 1 pm) with slurring of speech( 9 am to 1 pm)

xxx---

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CT Brain: Right post frontal hematoma extending deep with corona radiate with no mass effect/midline shift

The goal of the management of patients with acute stroke is to stabilize the patient. Severe hypertension is one of the major risk factors for hemorrhage from Heparin therapy. This patient was had Grade II hypertensive. Immediate initial evaluation with imaging and laboratory studies needed.   

vi) Delayed brain CT scan and treatment was fatal.

It is pertinent to note that the patient complained of paresthesia of the left limbs in the morning around 8:30 AM on 17.06.2009 which was immediately brought to the notice of the doctors taking round around the HOD of Cardiology Unit II, Dr. George Joseph who did respond to the frantic call of the Complainant No. 2 and rushed to see the patient. After seeing him Dr. George Joseph instructed the nurses to stop Heparin as patient seems to have suffered a mini-stroke and since the patient belongs to the Cardiology Unit III, it would be informed to the concerned doctors for further care.  

We note that CT scan got done after 4 hours, though the Radiology Department was hardly 5-7 minutes away from the patient’s ward. After a lapse of 2 hours after the onset of stroke the patient was shifted to the Semi-ICU of Thoracic surgery unit at around 10.30 AM and the CT Scan  conducted at around 12:30 PM. Thereafter as per neurology advice at 4 PM, the patient was treated with drugs to reduce the swelling of the brain.  The Complainants themselves at 16:59 collected the drugs from the Main Pharmacy. The doctors further advised for   stat   4 units of Fresh Frozen Plasma (FFP) and 4 to 6 units of Packed RBCs (PRBC), unfortunately  it was too late.  Thus in our considered view the delay in the diagnosis and treatment of the stroke became fatal in the instant case.

vii)     Rigid adherence to the protocols : this is very important point, indeed. 

Although the patient was in most urgent need of the diagnostic CT scan but it was delayed for getting a receipt of Rs. 1850/- towards CT scan charges. The hospital was aware that the complainants had already deposited 150000/- in advance. The OP is salient on the procedural aspects or protocols to be followed during emergency situation. Moreover, Dr. George Joseph after seeing the patient instructed the nurses to stop Heparin as patient seems to have suffered a mini-stroke. Though patient belongs to the Cardiology Unit III, but the proper attention from Dr. George Joseph and his team was expected at that time to avoid delay in management of stroke. It seems at that relevant time the rigid protocols prevailed over the medical ethics, which amounts to failure of duty of care.   

The “but for” causation test :

The onus is on the Complainants to establish “but for” approach to causation. It depends on the balance of probabilities, “but for” the OP- doctor/ hospital’s negligent act, the injury would not have occurred.  In Clements v. Clements, Supreme Court of Canada   2012 SCC 32 (Can LII),  at paras. 8-9, Chief Justice McLachlin described this test as follows:

8. The test for showing causation is the “but for” test.  The plaintiff must show on a balance of probabilities that “but for” the defendant’s negligent act, the injury would not have occurred.  Inherent in the phrase “but for” is the requirement that the defendant’s negligence was necessary to bring about the injury - - in other words that the injury would not have occurred without the defendant’s negligence.  This is a factual inquiry.  If the plaintiff does not establish this on a balance of probabilities, having regard to all the evidence, her action against the defendant fails.

9. The “but for” causation test must be applied in a robust common sense fashion.  There is no need for scientific evidence of the precise contribution the defendant’s negligence made to the injury.   

In the case on hand the “but for” causation test applicable. The complainants alleged that the OP fell below the accepted standard of care when they failed to despite the patient’s neurological decline after the administration of 3rd dose of Heparin in the morning on 17.6.2009 and moreover failed to hold future 4th Heparin dose administration. It was a direct result of the deviations from the accepted standard of care, the patient was improperly administered Heparin, causing an intra-cerebral haemorrhage and resulting in a stroke and death.   Had the doctors therein complied with the accepted standard of care, the patient would not have been over anti-coagulated and would not have suffered the brain haemorrhage that caused his stroke and the death. Thus, the “but for” causation test is applicable to the instant case.

4. It was held that the spirit in which CMC, Vellore was set up in 1900 cannot be a ground to overlook omission in the requisite standard / duty of care.

5. At the end the Commission awarded Rs. 25 lakhs compensation to the Complainants with interest 8% p. from the death of the Patient. i.e. from 2010 to 2020 !

6. This is a very complicated case and a lesson to be learnt for the Doctors. It again has the important element of maintaining proper medical records and there should not be any contradictions in it. Strangely, the National Commission which came heavily upon “printed informed consent”, seems to have given  clean chit to Doctors on the basis of the general informed consent. It has also touched the important and crucial part in any treatment i.e. the money. At one hand the Commission has made it clear that demanding Advance money for costly surgeries like CABG is nothing wrong, but at the same time it has stressed the important point that money can wait, but not the life. 

Nevertheless, "Pranam"  🙏🙏 to all the Doctors for their commitment and service in this Covid-19 pandemic. "Save the Saviors" 

Thanks and Regards

(Adv. ROHiT ERANDE)

Pune. ©