IN THE CONSUMER DISPUTES REDRESSAL COMMISSION, KOTTAYAM
Dated this the 11th day of August, 2021
Present: Sri. Manulal V.S. President
Smt. Bindhu R, Member
Sri. K.M. Anto, Member
C C No. 268/2016 (filed on 28/09/2016)
Petitioners : 1) M.C. Micheal,
S/o. Chacko,
Mannamplakkal House,
Chirakkadavu P.O.
Kanjirappally Taluk.
2) Jis Michael,
S/o. M.C. ,
-do-
3) Jins Michael ,
S/o. M.C.Michael ,
-do-
(Adv. Jolly James, Adv. Sumesh Andrews
and Adv. Thomas Joseph)
Vs.
Opposite Parties : 1) Director,
Carithas Hospital,
Thellakom P.O.
Kottayam – 686630.
(Adv. Preetha John K.)
2) Dr. Binoy Thomas,
Consultant Nephrologist,
Carithas Hospital, Thellakom
Kottayam – 686 630.
(Adv. Alex George, Adv. Joel Mathew and
Adv. Annu Mary Jose)
O R D E R
Sri. Manulal V.S. President
Crux of the complaint is as follows.
1st complainant is the father of the 2nd and 3rd complainants. Annamma Michael, who was the wife of the 1st complainant and the mother of the 2nd and 3rd complainants was under the treatment of Dr. Jose at 1st opposite party hospital from 2012 onwards. Thereafter she was under the treatment of the 2nd opposite party and while so kidney disease was diagnosed to her. Her serum creatinine level was 2.6 mg% on her 1st consultation. Serum creatinine level was found to be increased as 7.20 mg% on 09-10-2015. So the 2nd opposite party advised for an immediate dialysis for the said Annamma Michael and arteriovenous Fistula was created on that day itself by the 2nd opposite party. However without performing the dialysis, the said Annamma Michael was discharged on 14-10-2015. The opposite parties had levied Rs.35,000/- from the complainant for the creation of anteriovenous fistula. On 07-12-2015 when the said Annamma Michael consulted the opposite parties, it was found that her serum creatinine level was increased as 9.5mg%. Then also the opposite parties did not start the dialysis and sent back Annamma Michael to home with an advice to some medications. Thereafter on 10-12-2015, the said Annamma Michael has suffered chronic respiratory problem and was succumbed to death while on the way to hospital. It was alleged in the complaint that the said Annamma Michael died due to the negligent act of the opposite parties to render proper medical services to her. It is further alleged that the death of Annamma Michael was due to the non performance of the dialysis by the 2nd opposite party. It is averred in the complaint that whenever the said Annamma Michael consulted with the opposite parties for treatment, the opposite parties prescribed costly medicines and returned Annamma Michael without performing the dialysis, which was necessary for saving her life. It is further alleged in the complaint that the 2nd opposite party is not a competent person as a nephrologist. According to the complainants due to the death of Annamma Michael they suffered much mental agony and hardship. They were deprived from the monthly pension of said Annamma Michael, who is a retired teacher. Hence this complaint is filed by the complainants praying for an order for compensation of Rs.15 lakhs from the opposite parties.
Upon notice, opposite parties appeared before this Commission and filed their separate versions.
The version of the 1st opposite party is as follows.
The complainants are not consumers as contemplated under Consumer Protection Act. The patient was examined and treated by the 2nd opposite party as per the standard medical protocol, bestowing all care, caution and attention. The said Annamma Michael was undergoing the treatment for diabetes induced kidney disease under Dr. Jose, who is a nephrologist of the opposite party 1 hospital from December, 2012 onwards. Her serum creatinine was 2.6mg/dl on her 1st consultation, suggestive of chronic kidney disease stage IV. The patient was on continuous medication for diabetes, hyper tension, cardiac illness and kidney related complications. The medicines are absolutely necessary for retarding progression of chronic kidney disease and avoiding complications like acute coronary syndrome, anemia, bone mineral disease etc. The patient also had periodical checkups with cardiologist of opposite party 1st hospital from 2012 onwards.
On 09-10-15, the said Annamma Michael was admitted in the hospital with uncontrolled blood sugar and respiratory infection and she was treated there till 14-10-2015. As there was no indication for emergency dialysis, she was not dialysed. An arteriovenous fistualla creation was made after getting consent of bye standers and patient by a cardiac surgeon. No consent was taken for dialysis initiation on 13-10-2015. According to clinical practice guidelines arteriovenous fistula creation is the best preparation for dialysis which is to be created at least 6 weeks prior to a planned dialysis initiation as it takes 6 weeks time to become functional for dialysis initiation. The patient was discharged with stable condition on 14-10-15.
The patient came for routine outpatient consultation on 07-12-2015. She was asymptomatic. Eventhough the patient had not absolute indication for dialysis, dialysis initiation was suggested in view of progressive nature of kidney failure to avoid development of uremia related complications. For her if initiated, it would be 3 dialysis per week for lifelong. As a patient was asymptomatic, the patient and relatives asked for some time to discuss among themselves to make a decision as it is a life changing event for patient and family as well. No consent for dialysis was given by complainants as alleged in the complaint at any point of time.
The usual indication for initiation of dialysis are uncontrolled BP not responding to medications, severe edema, dyspnea due to fluid overload, alter mental status or seizures due to brain dysfunction, severe pruritus, high levels of potassium in blood, alteration in acid base level etc. But the patient had not such indication on 07-12-15. Further dialysis was suggested by the 2nd opposite party. But as patient was asymptomatic as there was no indication for dialysis on 07-12-15 and before getting a decision from the family members, the patient died due to cardiac problem which has no nexus with noninitiation of dialysis or other treatment provided to the patient by the 2nd opposite party in 1st opposite party hospital.
The 2nd opposite party is having required qualification for a nephrologist. He is having MBBS, MD General Medicine, DM nephrology and DNB nephrology. The treatment as per the standard protocol were provided to the patient by the 2nd opposite party. There is no negligence or deficiency of any kind from opposite parties and the opposite parties are not liable to compensate the complainants for the death of the patient. It is averred in the version that the complainants are attempting to make unjust enrichment at the expense of the opposite party without any truth or bonafides.
The 2nd opposite party filed version contenting as follows.
Annamma Michael was having uncontrolled blood sugar and respiratory infection and she was under the treatment of Dr. Jose from 19-12-2012 onwards. Her creatinine level which was 2.6 mg/dl on 29-12-2012 indicates that she has chronic kidney disease stage IV. From 20-10-2012 she was under the treatment of 2nd opposite party. Annamma Michael was admitted in the hospital on 09-10-2015 for the management of uncontrolled blood sugar and respiratory infection. Considering worsening of kidney disease the need for dialysis in due course was discussed with the relatives and arteriovenous fistula was implanted at her left hand on 13-10-2015. She was discharged with stable condition on 14-10-2015. The patient had no indication for emergency initiation of dialisys on 07-12-15. Though there was no indication for emergency dialysis initiation on that day, the need of life time dialysis was suggested with the patient and her relatives in view of the irreversible progressive nature of kidney disease. The dialysis initiation is to be based on the patient’s symptoms and signs and not on serum creatinine level. The allegation that at the time of every consultation, the opposite parties prescribed costly medicines to the patient and included to start the dialysis is false and denied. The installation of arteriovenus fistula is the primary preparation for the initiation of dialysis. The opposite party had given medicines to the Annamma Michael as per the international protocol of treatment for blood sugar, blood pressure, cardiac disease and kidney disease. Eventhough the dialysis initiation was suggested on 07-12-2015, when the patient came for routine checkup, the patient and her relatives sought time to discuss the matter with family members. The opposite parties had given the proper medicines for the health and reliefs of the patient. The creatinine level at 2.7 mg/dl and 9.5 mg/dl indicated the stage V of the chronic kidney diseases. Dialysis initiation is to be based on the patient symptom and signs and not on serum creatinine values. The serum creatinine level of 9.5/dl is not a parameter to initiation of dialysis as per the international protocol of treatment. The allegation that the said Annamma Michael died due to the noninitiation of dialysis and negligence on the opposite parties in running proper medical treatment to her is false and hence denied. The opposite parties are given proper treatment and care to the said Annamma Michael in accordance with the accepted international standard protocol. The reason for the death of a kidney patient, who is undergoing dialysis or not is her disease. The patient, who was having heart disease was undergoing treatment of Dr. Joby K. Thomas who is a Cardiologist of 1st opposite party hospital. The death following sudden respiratory problem on the way to hospital would point that the death was due to heart disease. The mere initiation of dialysis cannot evade its eventuality. The 2nd opposite party is a qualified nephrologist. The complainant is not entitled to any compensation from the opposite parties and opposite parties are not liable to compensate the complainant. The death of the said Annamma Michael was not due to the deficient act of opposite parties. There is no deficiency in service or negligence from the side of the opposite parties. Hence the complaint is liable to be dismissed.
Evidence consists of deposition of Pw1 , Pw2 and Dw1. Exhibits A1 to A5 were marked from the side of the complainants and B1 to B3 series were from part of the opposite parties.
Points
- Whether the complainants had succeeded to prove the deficiency in service and negligence on the part of the opposite parties?
- Reliefs?
Point number 1
The specific case of the complainants was that Annamma Michael who was the wife of the first complainant and the mother of the second and third complainant was under the treatment of Dr. Jose for diabetics at first opposite party hospital from 2012 onwards. While so Kidney disease was diagnosed to her when she was under the treatment of the second opposite party. Serum creatinine level was 3.54 mg% on her first examination. On 9-10-2015 it was found that the serum creatinine level was high as 7.20mg% . Then the second opposite party implanted AVF on 13-10-2015 after getting the consent of the patient and relatives. The said Annamma Michael was discharged on 14-10-2015. It is averred in the complaint that though the serum creatine level was 9.5mg% the opposite parties were reluctant to initiate dialysis and sent back her after prescribing some medicines. Thereafter on 10-12-2015 the said Annamma Michael was succumbed on the way to hospital due to chronic respiratory problems. Complainants allege that the death of Annamma Michael was due to the negligence of the opposite parties in rendering proper medical care by not performing the dialysis on 7-12-2105 or prior to that .
It is an admitted fact that the diseased was under the treatment of second opposite party doctor at first opposite party hospital from 20-10-2014 onwards. Pw2 who is the first complainant deposed that the deceased was under the treatment at first opposite party hospital for diabetes. He deposed that his wife was under the treatment of Dr. Jose Thomas and later on his advice she had been under the treatment of cardiologist at first opposite party hospital. On perusal of B1 we can see that the diseased was under the treatment of second opposite party doctor from 20-1-0-2014 onwards. On perusal of exhibit B1 we can see that serum creatinine level of the diseased was 2.6 Mg on 29-12-2012. On that day itself the consulting doctor referred the patient to Dr. Joby saying that the patient had diabetic nephropathy. Exhibit B1 proves that the diseased was under the treatment of nephrologist at first opposite party hospital from 13-6-2013 onwards. Moreover on perusal of exhibits B1 we can see that the serum creatinine level of the patient was gradually increasing from 29-12-2012 onwards. There is no dispute on the fact that the diseased was under the treatment of the second opposite party from 20-10-2014 onwards. According to the opposite parties as she was having uncontrolled blood sugar and respiratory infection she was admitted in the hospital from 9-10-2015 to 14-10-2015. On perusal of exhibit B1 we can see that her serum creatinine level was 7.2 mg% and blood urea level was 158.5 mg% on 9-10-2015. Total Protein level in urine was 7.4gm%. This indicates that the patient was suffering from chronic kidney disease at that time. Discharge summery issued by the first opposite party hospital proves that the diseased was a diabetic kidney decease stage 4 patient. Opposite parties contented that the they duly informed the patient and relatives about the kidney disease condition and also informed about the future hazards that may cause to the patient. On 13-10-2015 Arteriovenous fistula was done after getting consent from the patient and Pw2 who was the bystander. Exhibit B1 (2) is the consent letter given by the patient and Pw2 for the installation of AVf. Patient was dismissed on 14-10-2015 with an advice to review after 10 days. As per B1 her serum creatinine level was 8.2 and blood urea was 208 on 23-10-2015. It was recorded in exhibit B1 that the need for dialysis was explained to the patient on that day. Exhibit A1 proves that the serum creatinine level of the patient was 7.9 mg% and blood urea was 165mg% on 7-11-2015.
Pw2 deposed before the commission that they consulted the doctor on 7-12-2015 and the doctor had prescribed four injection and advised them to review on the completion of the said injuctions. Dw1 deposed that on 7-12-2015 he discussed with the patient and by stander about the need for HD initiation and admission. But the patient and by stander asked for conservative treatment analysis. According to Dw1 on that day the said Annama was asymptomatic on that day to start dialysis. She had no symptom of uremia. Dw1 deposed that on 7-12-2015 there was no life threatening indication for initiation of emergency dialysis. He further deposed that as per international protocol and guidelines the dialysis can be started if there is signs and symptoms of uremia. Counsel for the second opposite party relied on various texts books on dialysis and kidney disease managements.
Hand book of dialysis by John T. Daugirdas 10th edition describes that “An AV fistula cannot be used immediately as the fistula maturation process generally takes about 6–8 weeks. During the maturation process blood flow through the newly created fistula will gradually increase due to dilatation of both artery and vein.” Said text further states that Patients with a glomerularfiltration rate (GFR) of <30 mL/min per 1.73 m2 should be educated about all renal replacement modality options including peritoneal dialysis and renal transplantation. For those choosing hemodialysis, an AV fistula should be placed at least 6 months prior to the planned initiation of dialysis. In patients planning to start peritoneal dialysis, creation of an AV fistula is optional.
According to Kdoqi Clinical Practice Guidelines for Vascular Access Guideline 1. Patient preparation for permanent hemodialysis access 2006 A fistula should be placed at least 6 months before the anticipated start of HD treatments. This timing allows for access evaluation and additional time for revision to ensure a working fistula is available at initiation of dialysis therapy
According to Hand book of Dialysis by John T. Daugirdas 10th edition Dialysis can be initiated when the patient have Uremic syndrome. It further describes that “the uremic syndrome consists of symptoms and signs that result from toxic effects of elevated levels of nitrogenous and other wastes in the blood. Uremic patients commonly become nauseated and often vomit soon after awakening. They may lose their appetite such that the mere thought of eating makes them feel ill. They often feel fatigued, weak, and/or cold. Their mental status is altered; at first, only subtle changes in personality may appear, but eventually, the patients become confused and, ultimately, comatose. Signs of uremia in the modern age are less common, because patients now come to medical attention at a relatively early stage of uremia. Nevertheless, sometimes uremic patients presenting with a pericardial friction rub or evidence of pericardial effusion with or without tamponade may reflect uremic pericarditis, a condition that urgently requires dialysis treatment. Foot- or wrist-drop may be evidence of uremic motor neuropathy, a condition that also responds to dialysis. Tremor, asterixis, multifocal myoclonus, or seizures are signs of uremic encephalopathy. Prolongation of the bleeding time occurs and can be a problem in the patient requiring surgery.”
Benner & Rector’s Kidny 10th edition says that “Current clinical practice guidelines suggest that dialysis be initiated when patients become symptomatic from uremia, a change that often occurs at an estimated GFR between 5 and 10 mL/min/1.73 m2 . 69. Benner & Rector’s Kidney further stats that 76-78 Potential explanations for the higher mortality in patients who start dialysis early are an accelerated loss of residual kidney function, more frequent use of dialysis catheters, myocardial stunning, depression, and provider inexperience at a time when life-saving benefits from dialysis are low.78,79 Until the risks leading to increased mortality are better understood and can be modified, trends toward earlier start of dialysis in the absence of uremic complications should be discouraged”.
The said text further describes Symptoms of Uremia as; Metabolic Effects, Symptoms, and Signs of Uremia. Metabolic Increased oxidant levels, Reduced resting energy, expenditure Reduced body temperature, Insulin resistance ,Muscle wasting Amenorrhea and sexual dysfunction, Neural and Muscular Fatigue, Loss of concentration ranging to coma and seizures ,Sleep disturbances ,Restless legs, Peripheral neuropathy, Anorexia and nausea, Diminution in taste and smell, Itching Cramps, Reduced muscle membrane potential, Other Serositis (including pericarditis), Hiccups Granulocyte and lymphocyte dysfunction ,Platelet dysfunction and Shortened erythrocyte lifespan Albumin oxidation etc.
As per API text book of medicine absolute indication to start dialysis are fluid overload or pulmonary refractory to diuretics, uremia , accelerated hypertension poorly responsive to antihypertensive medication, blood urea nitrogen BUN > 100mg/ml and serum creatinine above 10mg/dl, persistent metabolic disturbances which are refractory to medical therapy.
The 2012 Kidney diseases improving global outcomes guidelines suggest that dialysis be initiated when there are signs or symptoms attributable to kidney failure (such as serositis, acid-base or electrolyte disorders not easily corrected medically, pruritis); an inability to control volume status or blood pressure; a progressive deterioration in nutritional status that is refractory to dietary interventions; or cognitive impairment.
Pw2, who is the husband of the diseased would deposed before the Commission that till the day of the sad demise there was no difficulty other than shortness of breath until the vomiting. During cross examination Pw2 deposed that an advice had been given by the second opposite party at the time of discharge that if any complications like respiratory problem or vomiting occurred the patient ought to have been admitted in the intensive care unit. She further deposed that such conditions did not occurred after that.. On a perusal of Exhibit B1 we cannot see any evidence to arrive at a conclusion that the diseased Annamma had symptoms of uremia on 7-12-2015.
According to second opposite party diseased Annamma having heart disease was undergoing treatment of DR. Joby K Thomas , who is a cardiologist of the first opposite party hospital. Pw2 would depose that the diseased was under the treatment of the cardiologist at first opposite party hospital. Schriers’s Diseases of the Kidney 9th edition and Comprehensive clinical nephrology by Feehally says that the reason for death for a kidney patient ,who is undergoing dialysis or not heart disease. Though the complainant alleges that the demise of Annamma was due to non initiation of the dialysis he did not adduce any evidence regarding the cause of death .
Another contention put forwarded by the complainant that the second opposite party does not have adequate qualification and knowledge to work as nephrologist. Exhibit B3 series proves that Dw1 who is the second opposite party had completed MBBs,MD in general medicine , DM Nephrology , and DNB nephrology degrees. Thus the allegation regarding the qualification and experience of the second opposite party would not sustain.
According to authoritative medical text books dialysis is technically more demanding, and initial results with the procedures were sometimes less than desirable. We have gone through the text books and articles on dialysis. The literature analysis shows the dialysis can be started when the symptoms of uremia is developed on the patient.
Counsel for the complainant relied on decisions of the Hon’ble Supreme court in Maharaja Agrasen Hospital . vs Master Rishabh Sharma (2019 STPL 13967SC) and Arun Kumar Manglik vs Chirayu Health and Medicre Private Ltd & Anr(2019 STPL 2797 SC). In Maharaja Agrasen Hospital . vs Master Rishabh Sharma (2019 STPL 13967SC) Hon’ble apex court has held that “Medical negligence comprises of the following constituents: (1) A legal duty to exercise due care on the part of the medical professional; (2) failure to inform the patient of the risks involved; (3) the patient suffers damage as a consequence of the undisclosed risk by the medical professional; (4) if the risk had been disclosed, the patient would have avoided the injury; (5) breach of the said duty would give rise to an actionable claim of negligence”.
It was held by the Hon’ble supreme court in Arun Kumar Manglik vs Chirayu Health and Medicre Private Ltd & Anr(2019 STPL 2797 SC) that in failing to provide medical treatment in accordance with medical guidelines, the respondents failed to satisfy the standard of reasonable care as laid down in the Bolam case and adopted by Indian Courts.
Counsel for the first opposite party placed reliance on decisions of NCDRC reported in 2017 (3) CPR 445(NC), 2018 (2) CPR 296(NC), 2018 (1) CPR 317(NC), 2018 (1) CPR 104(NC), 2017 (1) CPR 251(NC), 2017 (4) CPR 695(NC), 2017 (3) CPR 452(NC).
National Consumer Disputes Redressal Commission in Keshavrao V. Yadav vs Dr. J.V.S. Vidyasagar & Ors. on 1 January, 2021(2021) CPR 701 has held that
“30. The four 'Ds' of medical negligence are duty, dereliction (breach), direct cause (causa causens) and damages. Each of these four elements must be proved to have been present, based on a preponderance of the evidence, for negligence to be found. Nevertheless, a simple lack of care, an error of judgment or an accident is not a proof of negligence on the part of doctor. So long as the doctors follows a practice acceptable to the profession on that day he can't be held liable for negligence merely because a better alternative course of treatment was available or a more skilled doctor would not have chosen to follow or resort to that practice which the accused followed.
32. In the present case, it was an unfortunate and unexpected death of Dr. Sunil (Patient) even before the surgeons putting a knife for surgery. For me the 'causation' of medical negligence is not visible. In my view the general test for causation is that which requires the Complainant to show that the injury would not have occurred "but for" the negligence of the doctors - the Opposite parties. It is important that the Complainant has to establish on a balance of probabilities that the defendant's tortious act was a necessary cause of alleged injuries. I do not find any failure of duty or care from the doctors or there was any evidence to indicate any unexplained deviation from the standard protocol in the Operation Theatre. Further, I would like to rely upon the recent judgment of Hon'ble Supreme Court in the matter Vinod Jain Vs. Santokba Durlabhji Memorial Hospital and Ors., JT 2019 (3) SC 9, which has upheld the Order passed by this Commission exonerating the opposite parties i.e. the hospital and treating doctor from any medical negligence.”
The apex Court has consistently held in its decisions reiterates the principle that the standard of care which is expected of a medical professional is the treatment which is expected of one with a reasonable degree of skill and knowledge. A medical practitioner would be liable only where the conduct falls below the standards of a reasonably competent practitioner in the field.
Based on the above discussion, it cannot be attributed to medical negligence of the treating doctor or the hospital. Resultantly, the Consumer Complaint is dismissed.
Pronounced in the Open Commission on this the 11th day of August, 2021.
Sri. Manulal V.S. President Sd/-
Smt. Bindhu R, Member Sd/-
Sri. K.M. Anto, Member Sd/-
Appendix
Witness from the side of complainant
Pw1 - Asha Jiss
Pw2 – M.C. Michael
Witness from the side of opposite party
Dw1 – Dr. Binoy Thomas
Exhibits marked from the side of complainant
A1- Lab report dtd.07-11-15 from Caritas hospital
A2 – Lab report dtd.07-12-15 from Caritas hospital
A3- Letter dtd.19-01-2016 by Caritas hospital to 1st petitioner
A4 – Passbook of Annakutty K.U from SBT, Ponkunnam branch
A5 – Medical bill dtd.14-10-15 from Caritas hospital
Exhibits marked from the side of opposite party
B1 series– Case sheet of Annamma Michael from Caritas hospital (98 pages)
B2 series : Attested copy of certificates of Binoy Thomas (7 nos.)
By Order
Senior Superintendent
