No Proper Consent for High Risk Angioplasty : Gangaram Doctors Told to pay Rs 10 lakh
New Delhi: Sir Ganga Ram hospital and its vascular surgeon have been asked by the Delhi State Consumer Forum to pay compensation of Rs 10 lakh after the commission found them guilty for not taking proper consent for performing a high-risk carotid angioplasty on a high risk patient.
The case goes back to year 2005 and concerns 83 years old at the time of the treatment who had the history of bypass surgeries of two bypass surgeries. His 2002 tests revealed a low Left Ventricular Ejection Farction (LVEF) of 15% and his 2005 tests revealed slightly elevated creatinine and BUN levels. His MRI/MRA also revealed a blockage in the left internal carotid artery that was of the order of 70% but Given the patient’s age and general disability, his neurologist at Apollo hospital did not advise angioplasty and left the patient’s medical condition to be controlled by medication
The patient visited Sri Ganga Ram hospital and met Dr Rajiv Parakh on 27.08.2005. On looking at the medical history of the patient, Dr Parakh advised him to go for coloured Doppler test of both the arteries and recommended him to consult hospital where he had his bypass surgeries.
Doppler study revealed diffused intimal thickening in the bilateral common carotid and internal carotid arteries. Stenosis of about 70% at the left carotid bulb and of 71% in the left internal carotid arteries were found. There was also a circumferential plaque in the left common carotid bulb with extension into the left internal carotid artery causing significant luminal stenosis.
The complainants in their complaint stated that the doctor, based on the report informed them that the patient may suffer a paralytic stroke within a few hours or a few days. He was advised to submit himself to angioplasty immediately,without giving them time to makeup their minds.
The patient was admitted to Sri Ganga Ram hospital on the same day. the next day patient was referred to Department of Biochemistry of Ganga Ram hospital for certain tests. These tests revealed that his Creatinine and Bun unit to be very high and also the LVEF was 15% as against a normal range of 55 to 75%. The angioplasty was finally performed on the 4th day
The main contention of the complainants was that during angioplasty the patient suffered strokes infarcts because of embolism i.e. plaque breaking free and travelling to the brain and blocking blood supply. These risks were never explained. Before the forum Complainants submitted that the angioplasty takes about one hour whereas in the present case it lasted about 8 hours. The patient suffered from issues such as loss of vision, and loss of speech during the procedure. MRI also revealed MR findings are suggestive of diffused cerebral atrophy with bilateral high parietal infarcts and small periventricular lacunar infarcts.”
The patient was discharged from the hospital but his condition continued to deteriorate with time and he finally passed away a month after the discharge from the hospital.
The family then filed for compensation with the consumer forum, claiming alleged ‘medical negligence’ and ‘deficiency in service’ on the part of the OPs. Compensation to the tune of Rs.45,35,440/- alongwith interest @18% has been prayed for.
The allegations made by the family included as follows
- The procedure was done without explaining the inherent risks in angioplasty especially when the patient was compromised by age factor, medical history and his renal failure
- The allegation made on the hospital is that the consent form made no distinction between a surgical operation and a non-invasive intervention procedure like angioplasty. Even in the teeth of specific indications against operation, the consent form granted self absolution to the treating doctor and the hospital. Consent was taken at a juncture when the date of angioplasty was yet to be decided. Consent form remained undated.
- There was no record from the side of the hospital that there was an emergency or critical turn in patient condition that demanded angioplasty.
- The complainants alleged that during angioplasty the patient suffered strokes infarcts because of embolism i.e. plaque breaking free and travelling to the brain and blocking blood supply. These risks were never explained.
In their defence, the doctors submitted that procedure was done on 09.09.2005 when BUN was well within normal limits (19.6) and creatinine came down to 1.4 mg/DL. It was medically safe for the procedure. Clearance from consulting nephrologist was taken in this regard. The opponents claimed that the complainants did not present any medical literature or the expert’s opinion to substantiate their allegation of medical negligence. Dr. Rajiv Parakh himself addressed arguments. He was competant to perform the procedure
The court broke down the matter into 2. Most relevant question in the abovesaid factual matrix is whether with the medical status of the deceased Jiwan Ram, carotid angioplasty and stenting or a conservative treatment was the need of the hour.
The court observed that contention of the complainants is that the carotid angioplasty due to patient’s age, poor LVEF condition, high BUN and creatinine level was not advisable.
Dr Parakh rushed the patient into undergoing carotid angioplasty. There is no dispute with the facts that patient was 83 years old with an LVEF of 15%. He had high BUN and creatinine level besides plural effusion etc. Now another significant question arises whether doctors had explained to the patient or his attendants the benefits and risks of the procedure. Blockage of the carotid artery was to the tune of 70%. Whether there was an impending danger to the life of the patient?
The doctor has not denied the averment of the complainants that he had told the attendants that a stroke could occur in a few hours or in a few days. Nothing has been brought on record by the OPs that with 70% blockage in the carotid artery there was every chance of having a stroke in a few hours or in a few days. Whether a stroke, if any, could be avoided with medication or was also not explained by OP1 doctor. Nothing has been placed on record by the OPs to show that medical jurisprudence provides for carotid angioplasty even in a case of LVEF of 15%.
" Patient was almost asymptomatic at the time of his admission. It was during the procedure of carotid angioplasty that he had lost vision in the eyes. He had complained of it to Dr Parakh during the procedure. Even after the procedure, he made such a complaint to this attendants by way of gesture. Clearly, the patient had suffered a stroke(s) during angioplasty. Patient’s brain cells had been impaired. Blood supply in the artery had been occluded," the court added
The court noted that while complainant submitted various literature showing the risks- benefit of CAS . The literature showed that In high-risk cases if carotid stenting is considered there are several factors representing relevant contraindications which include Inability to take appropriate anti-platelet agents, Contrast allergy, Renal insufficiency and limited iliofemoral or brachial access. Age greater than 80 years was an independent risk factor.
The court noted that the doctors have failed to place any literature on record to show that in a case of a patient with 15% LVEF, compromised renal function and advance age of 83 years, CAS was preferably advisable to medication.
Commonsense dictates that opponent doctor ought to have refrained from undertaking CAS procedure. Present relates to medical science. Any conclusion should be based on scientific study and medical jurisprudence. In the absence of a clear-cut medical jurisprudence, I stay my hands in holding that Dr Parakh was guilty of ‘medical negligence’.
The court further went through the literature of the informed case, noting that while there was a pre-printed informed consent, the specific consent was not there noting that even the risk complication of Stroke was not mentioned in the consent
Coming to the case in hand, risk-benefit ratio was never explained to the patient or his attendants. The consequences of patient refusing CAS were never explained to him or his attendants. It is not the case of the parties that there was medical emergency where it was not possible to obtain informed consent. Patient did not have the occasion to make a balance judgement as to whether he should submit himself for CAS procedure or not. The plaque in the present case had broken loose and travelled to the blood vessels of the brain resulting in blockage of free flow of blood. Perusal of the consent form shows that the complication which took place in
the present case was never explained. On the contrary, consent form shows that emobilisation may be either reversible or may require emergency surgery. In the present case this was not reversible. No emergency surgery was conducted though rightly keeping in view the age of the patient.
The court then concluded that doctor and hospital were liable for compensation.
A multiplicand of Rs.10,00,000/- (rupess ten lakhs) would meet the ends of justice. Accordingly, Dr Parakh and Ganga Ram hospital are directed to pay jointly and severally a compensation to the tune of Rs.10,00,000/- (rupees ten lakhs) (which takes care of expenditure on medicine etc.) along with interest @8% per annum from the date of institution of the complaint till its realization.