State Consumer Disputes Redressal Commission
Pushpila Bist vs S. G. P. G. I. on 11 July, 2022
Cause Title/Judgement-Entry STATE CONSUMER DISPUTES REDRESSAL COMMISSION, UP C-1 Vikrant Khand 1 (Near Shaheed Path), Gomti Nagar Lucknow-226010 Complaint Case No. C/2000/121 ( Date of Filing : 04 May 2000 ) 1. Pushpila Bist a ...........Complainant(s) Versus 1. S. G. P. G. I. A ............Opp.Party(s) BEFORE: HON'BLE MR. Rajendra Singh PRESIDING MEMBER HON'BLE MR. SUSHIL KUMAR JUDICIAL MEMBER HON'BLE MR. Vikas Saxena JUDICIAL MEMBER PRESENT: Dated : 11 Jul 2022 Final Order / Judgement Reserved State Consumer Disputes Redressal Commission U.P. Lucknow. Complaint Case no. 121 of 2000 Ms. Pushpita Bisht aged about 27 years, D/o Late Prof. Ranbir Singh Bisht, R/o C-345, Indira Nagar, Lucknow. ....Complainant. Versus Sanjay Gandhi Post Graduate Institute of Medical Sciences, Raebareli Road through its Director. Dr. P. K. Goel, Cardiologist, Department of Cardiology, Sanjay Gandhi Post Graduate Institute of Medical Sciences, Raebareli Road, Present:- 1- Hon'ble Mr. Rajendra Singh, Presiding President. 2- Hon'ble Mr. Sushil Kumar, Member 3- Hon'ble Mr. Vikas Saxena, Member. Ms. Pushpila Bisht, Complainant in person Mr. Praveen Kumar &Mr. Anand Kumar, Counsels for the opposite parties. Date : 22 .08.2022 JUDGMENT
Per Mr. Rajendra Singh, Member: The present complaint has been filed under section 18 of the Consumer Protection Act 1986. In brief the facts of the complaint case are that, that the complaint has been filed against the negligent and deficient service and faulty treatment rendered by the opposite party no.2 as well as the Sanjay Gandhi Post Graduate Institute of Medical Sciences (SGPGI) which led to the ultimately demise of the complainant's father Prof. Ranbir Singh Bisht, who died at SGPGI on 25.09.1998 at 10 PM. The petitioner's late father was an eminent artist andPrincipal of the Government College of Arts and Crafts, Lucknow. He was recipient of several awards and his works of art were acclaimed in India and abroad. He was awarded the UNESCO Fellowship in the year 1967-68. He was given the fellowship of State Lalit Kala Academy and National Lalit Kala Academy. He was awarded the Chief Minister's Gold-Medal and he was also given the National award in the year 1965 in the field of arts. He was awarded the "Padam Shree" in the year 1991 and was given the Kala Ratn Award in the same year. On the occasion of 50 years of India's independence he was honoured with Kala Sewa Samman by the State Lalit Kala Academy in August 1998. He wrote several books and articles which have been published in reputed journals and magazines. His untimely demise on account of the negligent treatment provided by the opposite party no.2 has not only caused a void in the hearts of his family but has also robbed the country and the Art World of one of its finest art exponents.
Prof. Ranbir Singh Bisht was an angina patient since 1986. He was admitted to the Lari Cardiologist (King George Medical College Lucknow) when he suffered a heart attack in the month of February 1987. He was treated by Dr. Mansoor Hasan and later by Dr. R. K. Saran. In 1991 he was advised Angiography by Dr. R. K. Saran and was referred to the SGPGI.Angiography was cancelled at SGPGI at that time becausethe patient developed fever. Later on Angiography was ruled out by Dr. R. K. Saran as the heart condition had stabilised. In the month of August 1997 Prof. Ranbir Singh Bisht suffered an angina attack and he was put under the treatment of Dr. Mahesh Chandra. The treatment continued for about one year. On the advice of a doctor he was admitted to the SGPGI on 02.09.1998. He was examined by Dr. P. K. Goel, opposite party no.2, on the same day, who ordered and angiography which was fixed for 03.09.1998. It is relevant to mention here that Prof Bisht was admitted to the SGPGI on 02.09.98 with slight angina pains over the past few days and after being admitted to the medical intensive care unit ward, the patient also developed LVF (Left Ventricular Failure) on 03.09.98 at around 10 AM.
Before performing the angiography on 03.09.1998, the opposite party no.2 did not study the past medical history of Prof Bisht nor he sought any consent of opinion from the Nephrologist insofar as the damaged condition of his kidneys was concerned and which was evident from the pathological reports of 02.09.98 and 03.09.98, i.e. before the angiography took place. The serum creatinine of the patient was 3.2 which is much above the normal level and the patient was suffering from chronic renal failure but ignoring the same angiography was performed on him. Moreover, the risk of angiography was also not at all explained to the members of the family of the patient and if the patient had developed a renal problem, the angiography should have not been performed on him and this itself shows a negligent attitude of the opposite party no.2 towards the patient. It is also relevant to mention that the medication and treatment given to the patient was not administered properly by the opposite parties which is evident from the fact that though the pre-angiography reports show a high level of serum creatinine even then the angiography was performed on the patient which led to renal impairment of the patient wich further resulted in multiple organ failure. Moreover, the 'death certificate' was prepared by the opposite party no.2 himself in which even the patient's age was not written correctly and it was certified that the patient was admitted as a case of chronic renal failure and if it is taken to be true then the opposite party no.2 should not have advised angiography at that stage and that too without explaining it to the members of the family of the patient and without consulting a nephrologist because only naturalistic could have been in a better position to advise on whether angiography was to be performed on the patient or not.
Before conducting the angiography on 03.09.98, the opposite parties failed to conduct appropriate tests for the LVF (which the patient had developed on the day of angiography) and also for the respiratory infection which he had contacted after admission. On 02.09.98 an x-ray of the patient's chest was to be taken as per the doctor's advice as he was having cough and breathing problem and had just recovered from tuberculosis. The x-ray got washed out due to the technician's fault. The angiography was performed without the x-ray report on 03.09.98. The angiography should not have been performed on the patient. Even the angiography performed by the opposite party no.2 was done in a negligent manner without consulting a Nephrologist and therefore as a result immediately after the angiography the patient developed Acute Renal Shutdown (ARS) and there was no urine output. Peritoneal dialysis had to be performed and the patient's intestines were paralysed, Prof. Bisht heart was also affected and a pacemaker had to be implanted on him.
The opposite party no.2 performed the angiography negligently. An inferior dye was used and double the dose of the dye was injected, which caused the already damaged kidneys to shut down completely, besides causing other complications to the body organs from which the patient was never able to recover. There was complete callousness on the part of the opposite parties in treating the complainant's late father. Oxygen was improperly administered to the patient. Oxygen was started in the night of 03.09.98 because Prof. Bisht was dysenic. At first oxygen was given with water and later on oxygen was made dry on 04.09.98 as per the attending nurse. On 15.09.98 the opposite party no.2 removed the pacemaker from Prof. Bisht without the consent of his family members. Between 12.09.98 and 21.09.98 the opposite parties failed to provide proper treatment and care to the patient. Prof Bisht was prescribed a test for septicaemia called the DIC test. The staff in the CVTS and SICU failed to perform this test and after much delay the attendants of the patient were asked to get it done from outside so ultimately it was conducted outside SGPGI and that too by the attendants of the patient. This shows that the opposite parties adopted a very casual attitude towards the treatment of the patient because if it was not possible to carry out the test in the hospital, the doctor attending the patient that is opposite party no.2 should have immediately informed the attendants of the patient so that the required test could have been performed timely and the patient could have been saved from having any further complications.
There was a communication gap between the doctors attending the patient and the Resident Doctors. This is clearly evident from the fact that opposite party no.2 did not know the age of the patient till the time of his death and moreover, he has written a wrong age of the patient in the death certificate. The negligent and deficient services provided by the opposite parties led to the ultimately death of the Professor Ranbir Singh Bisht. The wards of the patient tried to get the documents relating to the hospitalisation of the patient and radiological reports, angiography report but the same were never handed over to them . Eventually they had to file a writ petition before the Hon'ble High Court at Lucknow two obtain the same but despite the order being passed by the Hon'ble High Court only few documents were given to the patient's wards and the contempt proceedings are still pending before the Hon'ble High Court. The wards of the patient had seen tampering in the patient's records at the hospital at the time when the patient was hospitalised and further the wards of the patient have reasons to believe that tampering in the records have been done. professor Ranbir Singh Bisht died on 25.09.98 at SGPGI Lucknow as such the cause of action has accrued within the jurisdiction of this Hon'ble commission. So the complainant prays for the following reliefs:
The Hon'ble Commission may pass in order directing the opposite parties to pay a sum of ₹ 19 lakhs as damages/compensation for providing deficient and negligent services.
To pass in order against opposite party no.2 imposing exemplary cost damagesnegligence in treating professor Ranbir Singh Bisht on his admission to the SGPGI.
To award the cost of the complainant and to pass any other order which this Hon'ble commission keeping in mind the facts and circumstances of the case deems fit.
The opposite parties filed their written statement stating that there was not any deficiency in service not any faulty treatment was given to the father of the complainant at any stage by the opposite parties. He was treated with utmost care without any kind of negligence. Looking into the social status of the patient and his social background, he was treated with utmost personalised care. From the contents of the complainant it is evident that the patient was suffering from long-standing coronary artery disease since 1986. With this background, he was advised angiography several times earlier when his general condition was far better. However, he was presented in an advanced stage of illness with history of worsening of chest pain, unstable angina and episodes of LVF which for a coronary patient is truly preterminal many times, unless intervened . Having presented on advice/recommendation of his doctor, he was thus promptly admitted to the institute of the opposite party on 02.09.98. At that stage, it was the best for the patient to do an angiogram with a hope to a definite cardiac treatment. At that stage, it was the best approach for the patient having refractory angina not amicable to medical treatment otherwise there was very likelihood of loosing the patient because of the cardiac disease itself. Accordingly, the patient was scheduled for angiography on 03.09.98.
A special care in respect of the patient was taken by the doctors and nurses of the institute of the opposite parties. The attending doctor had well studied the past medical history of the patient and the surgical reports and came to the conclusion that because of unstable cardiac status, and early angiography was essential to come to a definite diagnosis in such an advanced stage of illness. Since the procedure of angiography was being deferred since last so many years, as such it was essential to do angiography to come to a definite conclusion. The attending doctors were well aware that the patient had renal impairment and for which all the necessary precautions were taken like hydration and IV dopamine. At that stage, in the case of the patient, it was not necessary to insist for a nephrologist to see the patient before because there is nothing additional from patient's treatment point of view that the nephrologist does at this stage and decisions were taken based on merit the individual component of the disease i.e, cardiac and renal inpatient's total illness and the risk-benefit worked out. Besides, it is categorically admitted that renal impairment is not a contraindication to angiography which seems to be a misunderstanding in the complainant's mind and more so if the same is being called for an advanced or unstable stage of cardiac illness as was the case here. If this were not so, then no patient with diabetes and renal impairment which is not an uncommon combination would have angiography and definitive cardiac or renal treatment. The patient including the complainant were duly explained regarding all the risks and it duly signed a consent was taken.
Every pathological report and past medical history were well studied by the attending doctor before performing the procedure of angiography. Every factor including the risk factor were worked out and the patient and his attendants were also informed regarding the said risk factor as would be clear from perusal of document. The consent for angiography was also taken as would be clear from the document. The attending doctor, who is a well qualified and experienced senior doctor, for the better treatment of the patient came to the final conclusion after considering all the factors relating to the patient to perform the procedure of angiography upon the patient. There was absolutely no negligence on the part of the opposite parties. Having it in his age as 72 in place of 70 has absolutely no bearing to the treatment being given to the patient because the doctor was concerned about the total treatment of the patient. There is no procedure for indicating the date of birth or exact age. Normally one is presumed looking into the previous records of the patient. As per registration records of 1991, age of the patient is mentioned as 63.
It is not at all essential to perform x-ray on a sick patient prior to angiography. It is only a discretionary judgement of the attending doctor in as much as while doing angiography, the entire lung fields are visible on fluoroscopy even better than what is seen on x-ray. It is again reiterated that the poor renal status is not a contraindication to angiography. A calculated risk has to be undertaken depending upon the degree of renal impairment and the cardiac status of the patient. There are ways to go about depending upon the degree of renal impairment. Considering all these factors very carefully, the doctors have come to take a decision to perform angiography upon the patient. The very fact that the patient was having severe angina as admitted by the complainant, is the reason strong enough for any doctor to come to the conclusion to perform immediate angiography. Some increase in creatinine as alleged by the complainant and at times acute renal shutdown may happen in few cases after angiography in case of diabetic patient with renal impairment but this does not mean that no angiography can be performed if his cardiac status calls for the same. The patient did develop acute renal shutdown unfortunately but then whatsoever was needed relating to the problem of renal shutdown postprocedure was done as is evident from the own admission of the complainant that dialysis/pacemaker et cetera burden on the middle of the night again which goes to prove the commitment of the treating doctor to the patient.
There is nothing like an inferior quality dye. It is either ionic (routine) or non-ionic (three times the cost). Certainly, the routine that is ionic contrast (dye) was used in this case. This was done primarily as there was enough evidence in the medical literature that the type of contrasting used (ionic/non-ionic) may not have a significant bearing to the occurrence renal failure post angiography. It is categorically denied that an excess amount of dye (total dose 2 ml) was used in the case of the patient. It is correct that two vials (200 ml) were billed in this case but this does not mean that the said amount of dye has also been injected. These vials are available in 100 ml each. Even if five or 10 ml more is needed then second vial of 100 ml would have to be opened for necessary use. In the plaintiff, little more than 100 ml was required to be used. This is also to be taken in mind that at least 20-30 ml gets left in the tube/catheter used for injection and another 20-30 ml flows out during flushing of the catheter and lines and catheter exchanges which means no all dye that is procured is injected into the body of the patient. As a routine, anything between 90-150 ml dye gets injected, as was the case here, depending upon the number of catheter exchanges and the complexity of the coronary anatomy/disease in a diagnostic study. When the same patient undergoes a coronary intervention anything from 200 to upto 350/400 ml contrast may have to be injected and the acceptable the recommended dose limit is almost 4-5 ml /kg body weight making about 300 ml for a 60 kg man. The dye consumed could certainly not be restricted to less than normal in this case which would have been ideal primarily because of the complex coronary anatomy here but was still well within recommended limits. Thus neither any inferior dye was used nor excess doze of dye injected in the patient case.
Neither any carelessness whatsoever has been done in treating the patient nor improper oxygen was administered to the patient. He was given the oxygen as per requirement without any negligence or carelessness. The statement of complainant that first oxygen was given with water and thereafter dry oxygen was given is absolutely misconceived and it is not understandable as to what she wishes to convey by this fact. The pacemaker was removed primarily because patients heart rhythm had improved and no consent is required for the same. It is the clinician's decision to remove the pacemaker once the rhythm status improves as has happened in this case. The very fact that the doctors got him out of the cardiac rhythm disorder setup secondary to cardiac arrest as a result of the acute renal shutdown under the background of severe cautery disease and LVF episode itself shows commendable job done by the doctors team with utmost care in that session. It is also to understand that while treating an old man of 70 years of diabetes and long-standing heart disease and that too diffuse coronary disease which was detected on angiography and LVF and renal failure show final outcome may still not be successful. There is nothing called a test for septicaemia. Several tests are advised so as to get as much help as possible from investigative reports in situation of critically ill patient as in the present case but a presumptive treatment is started before hand. The patient was already on antibiotics during SICU stay to cover for septicaemia and watch for DIC. There was no delay in performing the DIC test (FDP/fibrinogen). Further it had no bearing on the patient's treatment/outcome. The death was not due to any negligence but looking into the previous records of the patient's advanced stage of illness. There was absolutely no communication gap as alleged by the complainant between the doctors.
Since all the said records are to be preserved by the hospital authorities, as a matter of policy, same were not be given to the patient or relative by the Institute of the respondents. If every patient would ask for the records which are being maintained by the central registry, it would create chaos. In fact, as per the procedure in the Institute for the respondent, all tests and reports are annxed with the file of the patient which are maintained by the central registry. As a matter of policy, same were not given to any patient/relative but kept as hospital records. However, on the directions of the Hon'ble High Court, the entire records asked for were supplied to the complainant. No tampering, whatsoever, was either done nor contemplated with the records. The patient died not because of any negligence/callous treatment but primarily because of the delayed presentation of the patient for proper treatment as a case of long standing angina and diabetes mellitus finally presenting with worsening chest pain, unstable angina, left ventricle failure, and renal failure already set in. It is a commendable job that the doctors did of at least taking up the challenge presented by such a patient and tried their best to see if any form of definite treatment could help the patient. However, as they were fighting against the odds of old case and advanced disease, they finally could not succeed and the patient was lost. The very fact that the patient could survive for nearly a month after it total cardiorespiratory arrest on 04.09.98 also goes to show that the doctors tried their best but the order of old age really worked against. "No man is IMMORTAL".
We have heard Ms. Pushpila Bisht in person and the counsel of the opposite parties, Mr. Anand Kumar. We have perused the pleadings, evidence and documents on record.
The complainant had stated that an inferior dye has been used and double the dose of the dye was injected. As for as ionic and non-ionic contrast media is concerned, The adverse effects of ionic and nonionic contrast media, were compared in a group of 44 healthy renal donors undergoing renal angiography as a screening procedure, for adverse reactions and change in renal function. 44 healthy renal donors, with normal renal function and no associated co-morbid conditions, who underwent renal angiography under DSA as a screening procedure for renal assessment were selected. Of them, 22 donors were randomly chosen to be given ionic contrast medium (Diatrizoate Sodium, Diatrizoate Meglumine) and 22 nonionic contrast medium (Iohexol and Iopamidol), in the dosage of 1 ml/kg body weight. They were assessed pre and 48 hours post procedure for vitals and laboratory assessment of blood (blood urea, serum creatinine), Urine (specific gravity, proteins, RBC etc.) and GFR by DTPA scan. RESULTS: Only mild type of adverse reactions like injection site pain, feeling of warmth and nausea were noted in both the groups. No adverse reactions of moderate or severe type were noted in either group. No significant change in the renal function was noted in both the groups as assessed by blood analysis (blood urea & Serum creatinine), urine analysis and GFR by DTPA scan 48 hours post contrast administration.
CONCLUSION:These results suggest that in dosage of 1ml/kg body weight, which is adequate for good opacification and necessary clinical information, ionic contrast media are as safe as more expensive nonionic media in healthy patients with no co-morbid conditions.
Nephrotoxicity of ionic and nonionic contrast media in 1196 patients: A randomized trial. The incidence of nephrotoxicity occurring with the nonionic contrast agent, iohexol, and the ionic contrast agent, meglumine/sodium diatrizoate, was compared in 1196 patients undergoing cardiac angiography in a prospective, randomized, double-blind multicenter trial. Patients were stratified into four groups: renal insufficiency (RI), diabetes mellitus (DM) both absent (N = 364); RI absent, DM present (N = 318); RI present, DM absent (N = 298); and RI and DM both present (N = 216). Serum creatinine levels were measured at - 18 to 24, 0, and 24, 48, and 72 hours following contrast administration. Prophylactic hydration was administered pre- and post-angiography. Acute nephrotoxicity (increase in serum creatinine of ≥1 mg/dl. 48 to 72 hours post-contrast) was observed in 42 (7%) patients receiving diatrizoate compared to 19 (3%) patients receiving iohexol, P < 0.002. Differences in nephrotoxicity between the two contrast groups were confined to patients with RI alone or combined with DM. In a multivariate analysis, baseline serum creatinine, male gender, DM, volume of contrast agent, and RI were independently related to the risk of nephrotoxicity. Patients with RI receiving diatrizoate were 3.3 times as likely to develop acute nephrotoxicity compared to those receiving iohexol. Clinically severe adverse renal events were uncommon (N = 15) and did not differ in incidence between contrast groups (iohexol N = 6; diatrizoate N = 9). In conclusion, in patients undergoing cardiac angiography, only those with pre-existing RI alone or combined with DM are at higher risk for acute contrast nephrotoxicity. The incidence of acute nephrotoxicity in these high-risk patients is significantly less with the nonionic contrast media iohexol compared to the ionic contrast agent diatrizoate.
Non-ionic contrast medium, iopromide (Ultravist), was comparedwith ionic contrast medium,ioxitalamate (Telebrix), for efficacy and safety in 63 patients undergoing left ventriculography. In all patients, adverse symptoms and signs including pain, heat sense, nausea, vomiting, etc., were checked during and shortly after the injection. Blood pressure, heart rate, EKG and left ventricular pressure were also monitored during the study, and CBC, UA, BUN and creatinine were checked before and 24 hours after the study. The cineangiographic films were analysed and compared by 2 radiologists for the quality. Serious adverse effect did not occur in any case. Minor effects, especially nausea, were lee frequentlycausedby non-ionic contrast medium than by ionic contrast medium,andheat sense to non-ionic contrast medium was less severe than to ionic contrast medium. Except slightly elevated LVEDP at 1.5 minutes after the study in patients given ionic contrast medium, there was no significant change of electrophysiologic parameters and laboratory findings in both groups. In regard to image quality, there was no significant difference between ionic and non-ionic contrast medium.
Thus non-ionic contrast medium, iopromide, appears to be safer for use in left ventriculography than the conventional ionic contrast medium, particularly in those patients at high risk of adverse effects. A study says compared to the standard protocol with use of 80 ml of Visipaque 270®, two of the three tailored protocols −1.0 ml/kg and 1.5 ml/kg - yielded similar or better results with regard to ME, along with excellent or good image quality. Compared with each other, the two higher doses were comparable in terms of ME, SNR, and CNR, whereas both provided significantly better ME, SNR, and CNR as well as image quality than 0.5 ml/kg. However, administration of 1.5 ml/kg mainly improved arterial enhancement of the cervical vessels and circle of Willis, whereas significant effects on the posterior circulation were only detectable for SNR and CNR in the VA and BA. The dose of 1.0 ml/kg produced significantly higher ME in the cervical vessels, the ACA, MCA, VA, and PICA, whereas differences to the standard protocol were not significant for SNR and CNR. For the dose of 0.5 ml/kg, ME, SNR, and CNR were mainly inferior to the standard protocol and especially to the body weight-adjusted doses of 1.0 ml/kg and 1.5 ml/kg. This effect might be due to substantial dilution of the small CM bolus in the large and medium-sized cerebral arteries compared to the standard dose and higher weight-adjusted doses. In the small cerebral arteries (AcomA, PICA, and AICA), the difference in ME, SNR and CNR between 0.5 ml/kg and the standard dose is no longer significant. Presumably, the effect of a larger contrast medium bolus is particularly evident in the large cervical and intracranial arteries whereas the bolus dilution in the smaller cerebral arteries is similar in all groups independent of the initial bolus size.
The opposite parties have stated in para 14 of their written statement that an excess amount of dye (total dose 2 ml) was used in the case of the patient. It is not clear that whether it is 2 ml/kg bodyweight? The study shows that it is sufficient between 1 ml to 1.5 ml/kg bodyweight. The opposite parties have said that the acceptable recommended dose limit is almost 4-5 ml/kg body weight. The excess amount may cause serious effect in various part of the body. Though there is very much difference between ionic and non-ionic contrast medium as far as dose is concerned it should be according to prescribed limits but it is more than the prescribed limits. In a study it is asserted that patients with diabetes and kidney disease, it may be preferable to perform angiography as a staged procedure or utilise alternative non-contrast imaging techniques to obtain the desired information rather than to exceed the MACD(Maximum Allowable Contrast Dose). It is clear that if there is a renal problem, the dye may increase the renal problem.
It is well known that iodinated radiographic contrast media may cause kidney dysfunction, particularly in patients with preexisting renal impairment associated with diabetes. This dysfunction, when severe, will cause acute renal failure (ARF). Acute renal failure is a well known complication of procedures that involve iodinated contrast media.1 Despite this, contrast medium induced nephropathy accounts for about 12% of all cases of hospital acquired renal failure.2 Prevention of this type of nephropathy is crucial as it is associated with prolonged hospital stay, risk of permanent renal impairment, and a more than fivefold increase in mortality. We report a case of acute renal failure in a woman with chronic renal disease who was investigated for metastatic breast cancer with contrast enhanced computed tomography. This case shows the importance of carrying out a risk assessment for contrast medium induced nephropathy before using procedures that involve iodinated contrast media.
Case report An 81 year old woman with type II diabetes was admitted after a hypoglycaemic episode. She had a four week history of non-productive cough, which failed to resolve with antibiotics. She had been treated with surgery and radiotherapy for breast cancer 13 years previously. She also had stage 3 kidney disease and hypertension.
Breast examination was normal but there were signs of a left sided pleural effusion. Chest x ray showed a possible left sided coin lesion and pleural effusion. Her white blood cell count was 5.6×109/litre, C reactive protein was 15 mg/litre, and the pleural aspirate was an exudate containing 38 g/litre protein and 0.5×109/litre white blood cells. Plasma creatinine was 224 μmol/litre, which was not very different from her preadmission value. In view of the history of breast cancer, contrast enhanced computed tomography of the chest and abdomen was performed. No abnormalities were detected in the lungs, but a lesion, suggestive of metastasis, was detected in the left adrenal.
Over the next two days, the patient became increasingly nauseous and anorexic. Creatinine rose to 392 μmol/litre (figure). Despite supportive treatment for acute renal failure she became anuric, her blood pressure began to drop, and creatinine rose to 664 μmol/litre. She was transferred to the intensive care unit, where haemofiltration was started. Her renal function started to recover over the next few days and her condition began to improve.
Figure 1 Serum creatinine values during admission in a woman with contrast medium induced acute renal failure Discussion Nephropathy induced by contrast medium is defined as an impairment in renal function that occurs within 72 hours of giving contrast medium.5 This impairment is characterised by an increase in serum creatinine of at least 44 μmol/litre or 25% above the baseline. Creatinine typically peaks three to five days after contrast administration and returns to baseline values within two weeks. Renal replacement therapy is needed in a minority of patients, and in-hospital mortality may be as high as 62% in these cases. No specific treatment is available for contrast medium induced nephropathy and management is supportive.
Risk factors for contrast medium induced nephropathy Pre-existing renal insufficiency Diabetes mellitus Age > 75 years Concurrent use of nephrotoxic drugs (non-steroidal anti-inflammatory drugs, aminoglycosides) Dehydration Hypotension Heart failure Cirrhosis Nephrotic syndrome Hypertension The box shows the key risk factors for developing contrast medium induced nephropathy. Underlying impairment of renal function, particularly if secondary to diabetes, is the most important risk factor, and the associated incidence of contrast nephropathy is 12-27%. This compares with an incidence of 0-5% in patients with normal renal function. Serum creatinine should ideally be measured in all patients before giving contrast medium, but particularly if a history of renal impairment or diabetes is present. Serum creatinine, however, is a poor indicator of renal function. The best measure of renal function--and therefore risk of contrast nephropathy--is the glomerular filtration rate. The rate can be estimated from serum creatinine using the Cockroft-Gault formula or the modification of diet in renal disease formula.7 It is especially useful to estimate the glomerular filtration rate in patients with borderline serum creatinine--a value of less than 60 ml/min/1.73 m2 predicts increased risk of contrast nephropathy.
If risk factors are present then an alternative imaging technique should be used. If however, administration of contrast medium is deemed necessary, then several steps can be taken to reduce risk. The most important of these is adequate hydration. The most effective regimen has not been defined, but one study showed that intravenous hydration with normal saline at a rate of 1 ml/kg/hour for 24 hours, beginning 12 hours before administration of the contrast medium, was associated with a significantly lower incidence of contrast nephropathy (3.7%) compared with unrestricted oral hydration (34.6%).9 Isotonic sodium bicarbonate has been shown to be superior to normal saline in preventing contrast nephropathy, but further evidence is needed to support this intervention. Nephrotoxic drugs increase the risk of developing contrast nephropathy, and it is recommended that these drugs be stopped at least 24 hours before investigation.11 In addition, use of the minimum volume of low osmolar or iso-osmolar contrast media is associated with a lower incidence of contrast nephropathy compared with high osmolar media. Oral N-acetylcysteine has been used as a prophylactic treatment for contrast nephropathy, but there is currently insufficient evidence to advocate its use. Daily monitoring of renal function after contrast administration in high risk patients enables early diagnosis and treatment of renal failure.
We did not perform risk assessment for the development of contrast nephropathy in our patient. We did not provide the relevant clinical details when we ordered computed tomography and the necessary precautions were not taken. In retrospect, this was a serious oversight. Contrast nephropathy is highly underestimated. A retrospective study of 89 patients undergoing contrast enhanced computed tomography showed that none had creatinine concentrations documented on the request card. Consequently, steps to reduce risk were taken in only two of 10 patients at risk.
This case emphasises the role of the clinician in preventing contrast medium induced nephropathy. A risk assessment must be performed and details of this should be provided to the radiology department. If it is deemed necessary to give contrast medium to patients with risk factors, measures must be taken to prevent renal failure from developing. Nowadays the doctor uses minimum quantity of the dye for angiography and it may be from 6 ml to 10 ml per person .So the quantity used in the case of the patient is on the higher side. It's side effect is that it increases the creatinine level and also affect adversely on the kidneys. This angiography was performed on 03.09.98 and the surgical report dated 02.09.98 showing the creatinine at 3.2. On 03.09.98 the creatinine was 2.50 and in another report of the same day the level of creatinine is shown as 0.4 but on the very next day i.e. the level of is shown as 3.20. On the next Day 06.09.98, the creatinine is 3.6 and thereafter on subsequent days it is 5.7, 3.6, 3.2, 3.8 and so on. It is clear here that after angiography the level of creatinine increased. So it adversely affected the kidney.So in this case it is clear that the dose of ionic or non-ionic contrast was more than the required quantity. This dye directly affects the kidney.
From the facts of the case it is clear that the patient was known case of angina since 1986. There was a pacemaker in his body. The opposite parties have admitted in their written statement,"The pacemaker was removed primarily because patients heart rhythm had improved and no consent is required for the same. It is the clinician's decision to remove the pacemaker once the rhythm status improves as has happened in this case".It is really strange that the pacemaker has been removed without the consent of the patient or his family members. Whenever any pacemaker is inserted in the body, it is not a routine process. Before your pacemaker procedure, your doctor and medical team will recommend various tests to confirm that you are likely to benefit from having a pacemaker:
Electrocardiogram (EKG or ECG): This quick, painless test measures the heart's electrical activity and records any disturbances in heart rhythm.
Stress Test: Sometimes your doctor will recommend that a stress test be performed along with an electrocardiogram to monitor your heart's electrical activity during physical activity, such as walking on a treadmill or riding an exercise bike.
Echocardiogram: This test uses sound waves to create a moving picture of your heart. The information provided by this test can help your doctor see the heart's chambers, walls, muscles and valves.
Holter Monitoring: Your doctor may recommend that you wear a device for several hours or up to 2 days as you go about your regular routine. The device, called a Holter monitor, records your heart's rate and rhythm.
Depending on your overall health and any risk factors, your doctor may recommend other tests as well. After all these tests, if there is need of pacemaker, the concerned Dr advice for the pacemaker. Every person has a life depending on its battery and usage. Better to know more about the pacemaker, its function and circumstances under which it is removed.
A pacemaker is a small device that's placed (implanted) in the chest to help control the heartbeat. It's used to prevent the heart from beating too slowly. Implanting a pacemaker in the chest requires a surgical procedure.
A pacemaker is also called a cardiac pacing device.
Types Depending on your condition, you might have one of the following types of pacemakers.
Single chamber pacemaker. This type usually carries electrical impulses to the right ventricle of your heart.
Dual chamber pacemaker. This type carries electrical impulses to the right ventricle and the right atrium of your heart to help control the timing of contractions between the two chambers.
Biventricular pacemaker. Biventricular pacing, also called cardiac resynchronization therapy, is for people who have heart failure and heartbeat problems. This type of pacemaker stimulates both of the lower heart chambers (the right and left ventricles) to make the heart beat more efficiently.
Why it's done A pacemaker is implanted to help control your heartbeat. Your doctor may recommend a temporary pacemaker when you have a slow heartbeat (bradycardia) after a heart attack, surgery or medication overdose but your heartbeat is otherwise expected to recover. A pacemaker may be implanted permanently to correct a chronic slow or irregular heartbeat or to help treat heart failure.
The heart's conduction system Open pop-up dialog box How your heart beats The heart is a muscular, fist-sized pump with four chambers, two on the left side and two on the right. The upper chambers (right and left atria) and the lower chambers (right and left ventricles) work with your heart's electrical system to keep your heart beating at an appropriate rate -- usually 60 to 100 beats a minute for adults at rest.
Your heart's electrical system controls your heartbeat, beginning in a group of cells at the top of the heart (sinus node) and spreading to the bottom, causing it to contract and pump blood. Aging, heart muscle damage from a heart attack, some medications and certain genetic conditions can cause an irregular heart rhythm.
PacemakerOpen pop-up dialog box What a pacemaker does Pacemakers work only when needed. If your heartbeat is too slow (bradycardia), the pacemaker sends electrical signals to your heart to correct the beat.
Some newer pacemakers also have sensors that detect body motion or breathing rate and signal the devices to increase heart rate during exercise, as needed.
A pacemaker has two parts:
Pulse generator. This small metal container houses a battery and the electrical circuitry that controls the rate of electrical pulses sent to the heart.
Leads (electrodes). One to three flexible, insulated wires are each placed in one or more chambers of the heart and deliver the electrical pulses to adjust the heart rate. However, some newer pacemakers don't require leads. These devices, called leadless pacemakers, are implanted directly into the heart muscle.
Risks Complications related to pacemaker surgery or having a pacemaker are uncommon, but could include:
Infection near the site in the heart where the device is implanted Swelling, bruising or bleeding at the pacemaker site, especially if you take blood thinners Blood clots (thromboembolism) near the pacemaker site Damage to blood vessels or nerves near the pacemaker Collapsed lung (pneumothorax) Blood in the space between the lung and chest wall (hemothorax) Movement (shifting) of the device or leads, which could lead to cardiac perforation (rare) How you prepare Before your doctor decides if you need a pacemaker, you'll have several tests done to find the cause of your irregular heartbeat. Tests done before you get a pacemaker could include:
Electrocardiogram (ECG or EKG). This quick and painless test measures the electrical activity of the heart. Sticky patches (electrodes) are placed on the chest and sometimes the arms and legs. Wires connect the electrodes to a computer, which displays the test results. An ECG can show if the heart is beating too fast, too slow or not at all.
Holter monitoring. A Holter monitor is a small, wearable device that keeps track of the heart's rhythm. Your doctor may want you to wear a Holter monitor for 1 to 2 days. During that time, the device records all of your heartbeats. Holter monitoring is especially useful in diagnosing heartbeat problems that occur at unpredictable times. Some personal devices, such as smartwatches, offer electrocardiogram monitoring. Ask your doctor if this is an option for you.
Echocardiogram. This noninvasive test uses sound waves to produce images of the heart's size, structure and motion.
Stress test. Some heart problems occur only during exercise. For a stress test, an electrocardiogram is taken before and immediately after walking on a treadmill or riding a stationary bike. Sometimes, a stress test is done along with echocardiography or nuclear imaging.
What you can expect Before the procedure You'll likely be awake during the surgery to implant the pacemaker, which typically takes a few hours. A specialist will insert an IV into your forearm or hand and give you a medication called a sedative to help you relax. Your chest is cleaned with special soap.
Most pacemaker implantations are done using local anesthesia to numb the area of the incisions. However, the amount of sedation needed for the procedure depends on your specific health conditions. You may be fully awake or lightly sedated, or you may be given general anesthesia (fully asleep).
During the procedure One or more wires are inserted into a major vein under or near your collarbone and guided to your heart using X-ray images. One end of each wire is secured at the appropriate position in your heart, while the other end is attached to the pulse generator, which is usually implanted under the skin beneath your collarbone.
A leadless pacemaker is smaller and typically requires a less invasive surgery to implant the device. The pulse generator and other pacemaker parts are contained in a single capsule. The doctor inserts a flexible sheath (catheter) in a vein in the groin and then guides the single component pacemaker through the catheter to the proper position in the heart.
After the procedure You'll likely stay in the hospital for a day after having a pacemaker implanted. Your pacemaker will be programmed to fit your heart rhythm needs. You'll need to arrange to have someone drive you home from the hospital.
Your doctor might recommend that you avoid vigorous exercise or heavy lifting for about a month. Avoid putting pressure on the area where the pacemaker was implanted. If you have pain in that area, ask your doctor about taking medicines available without a prescription, such as acetaminophen (Tylenol, others) or ibuprofen (Advil, Motrin IB, others).
Special precautions It's unlikely that your pacemaker would stop working properly because of electrical interference. Still, you'll need to take a few precautions:
Cellphones. It's safe to talk on a cellphone, but keep your cellphone at least 6 inches (15 centimeters) away from your pacemaker. Don't keep your phone in a shirt pocket. When talking on your phone, hold it to the ear opposite the side where your pacemaker was implanted.
Security systems. Passing through an airport metal detector won't interfere with your pacemaker, although the metal in the pacemaker could sound the alarm. But avoid lingering near or leaning against a metal-detection system.
To avoid potential problems, carry an ID card stating that you have a pacemaker.
Medical equipment. Make sure all your doctors and dentists know you have a pacemaker. Certain medical procedures, such as magnetic resonance imaging, CT scans, cancer radiation treatment, electrocautery to control bleeding during surgery, and shock wave lithotripsy to break up large kidney stones or gallstones could interfere with your pacemaker.
Power-generating equipment. Stand at least 2 feet (61 centimeters) from welding equipment, high-voltage transformers or motor-generator systems. If you work around such equipment, ask your doctor about arranging a test in your workplace to determine whether the equipment affects your pacemaker.
Devices that are unlikely to interfere with your pacemaker include microwave ovens, televisions and remote controls, radios, toasters, electric blankets, electric shavers, and electric drills.
Results Having a pacemaker should improve symptoms caused by a slow heartbeat such as fatigue, lightheadedness and fainting. Because most of today's pacemakers automatically adjust the heart rate to match the level of physical activity, they may can allow you to resume a more active lifestyle.
Your doctor should check your pacemaker every 3 to 6 months. Tell your doctor if you gain weight, if your legs or ankles get puffy, or if you faint or get dizzy.
Most pacemakers can be checked by your doctor remotely, which means you don't have to go into the doctor's office. Your pacemaker sends information to your doctor, including your heart rate and rhythm, how your pacemaker is working, and how much battery life is left.
Your pacemaker's battery should last 5 to 15 years. When the battery stops working, you'll need surgery to replace it. The procedure to change your pacemaker's battery is often quicker and requires less recovery time than the procedure to implant your pacemaker.
Pacemakers and end-of-life issues If you have a pacemaker and become terminally ill with a condition unrelated to your heart, such as cancer, it's possible that your pacemaker could prolong your life. Doctors and researchers vary in their opinions about turning off a pacemaker in end-of-life situations.
Talk to your doctor if you have a pacemaker and are concerned about turning it off. You may also want to talk to family members or another person designated to make medical decisions for you about what you'd like to do in end-of-life care situations.
Most pacemakers are permanently implanted because people with certain heart conditions need to have them for life. However, some people only need to have a pacemaker for a while--such as after they have a procedure or survive a medical event like a heart attack. Eventually, they will have to undergo another surgery to have the device removed, which has risks.
Now, researchers at Northwestern University and George Washington University have created a temporary pacemaker that dissolves in place and is reabsorbed by the body when it's no longer needed, making surgery to remove it unnecessarily. Their findings were published in Nature Biotechnology last month.
Fred Kusumoto, MD, president of the Heart Rhythm Society, calls the pacemaker "an exciting and innovative advance". Kusumoto was not involved in the study.
Disappearing Act The new dissolvable pacemaker is a small, flat, patch-like device that is placed on the surface of the heart and sutured in place. All of the components dissolve (or "bioresorb") over the course of five to seven weeks--similar to dissolvable stitches. This process eliminates the need for another surgery to remove the device.
Unlike other pacemakers, which use wire leads connected to a battery outside of the body, the new transient device is powered by radio frequency communication. The small amounts of metal in the device are made of magnesium and tungsten that are biocompatible and bioresorbable.
When a loved one in the family dies of natural causes, oftentimes it's due to old age. If a loved one in your family passes away and they used a pacemaker during the later years of their life, but requested that they be cremated upon their death, then pacemaker removal after death is required. The person in charge of seeing to the last wishes of the deceased should also make certain that they instruct either the staff in the mortuary or the funeral home that their loved one had a pacemaker and it must be removed.
Why does the pacemaker need to be removed before cremation?
Many pacemakers use a special sealant on their casing which, when exposed to extreme heat and pressure (as during the cremation process), can explode. The reason so many crematories require pacemaker removal after death is to avoid the damage caused to the crematory chamber from flying metal during the cremation process. The repairs would be extremely costly which is why pacemakers are usually removed before cremation.
Who can remove a pacemaker after death?
Since the person having the pacemaker removed is no longer living, there is no need for a doctor to remove the pacemaker after death. Either someone working in the hospital morgue or the mortician working at the funeral home you chose will be able to remove the pacemaker from your loved one's body. Of course, these people are trained professionals and you can rest assured that they will treat your loved one with the respect and dignity they deserve.
What happens after the pacemaker is removed?
After a pacemaker is removed, the manufacturer has the technician send it back to the manufacturer so that it can be recycled or disposed of properly. Some funeral homes make the decision to donate used pacemakers to charities that refurbish these pacemakers (It's important to understand that they cannot be reused immediately, but must be refurbished due to blood cross contamination issues) so that those less fortunate can have access to this life saving piece of equipment.
Pacemaker removal after death is an important thing to discuss with your doctor or funeral director when making plans for your funeral and afterlife care or the afterlife care of a loved one. Take the precaution of mentioning it until you feel that the disposal has been properly discussed and you feel that they will handle the procedure with care.
Pacemaker and Defibrillator Extraction What is a Pacemaker or ICD Lead?
A Pacemaker or Implantable Cardioverter Defibrillator consists of the device placed under the skin and one or more leads connecting it to the heart. A lead is a device that measures the passage of electrical signals. Leads are used in electrocardiograms to record the electrical activity of the heart. Leads are also used with pacemakers or Implantable Cardioverter Defibrillator devices (ICDs) to detect abnormal beating of the heart, and to deliver electrical impulses to the heart, in order to correct the abnormal heartbeat, or rhythm.
Why does a pacemaker or defibrillator lead need to be removed?
The most common reason is infection with bacteria, either on the lead itself or around the pacemaker or defibrillator. The infection may be associated with erosion of the pacemaker or defibrillator through the skin. Until all artificial material has been removed, the body is not able to completely clear the infection even though antibiotics may temporarily suppress the infection. A lead may also need to be removed because it is not working properly or is unnecessary.
How are leads removed?
Scar tissue grows around the lead within the veins and the heart. This holds the lead in place and can make difficult to remove. The procedure is usually performed under general anaesthesia so the patient is asleep. An incision is made through the old pacemaker implant scar and the pacemaker is removed. A metal or plastic tube (called a sheath) is inserted over the lead and pushed along its length. The sheath breaks up the scar tissue and allows the lead to be removed. Special sheaths can be connected to a laser, which is very effective in breaking up the scar tissue. Sometimes a tube is inserted into a vein in the neck or leg so that the lead can be snared and pulled out. In some circumstances the only way to remove the leads is by open heart surgery.
Is lead removal successful?
More than 95% of all leads can be completely removed. In a small number of patients the tip of the lead is left behind in the heart and this usually does not cause any further problem. In rare cases a large portion of the lead cannot be removed and further treatment depends on the particular situation.
What are the risks of lead removal?
This procedure carries a 2% risk of major complications including death, serious bleeding, stroke, brain damage, heart valve damage and the need to perform emergency open-heart surgery. These complications happen because of tearing the heart or a vein, which can cause sudden severe bleeding. 2% means that: out of 100 patients undergoing a lead removal procedure, 2 will have a serious complication. The risk of death from the procedure is small - about 3 in 1000. The risk of complications at the Royal Melbourne Hospital is similar to the risk at other major hospitals in Australia and overseas and is similar to the risks involved in open-heart surgery such as bypass surgery. The longer the lead has been implanted, the greater the risk of complications.
If problems occur during lead removal the only treatment may be emergency heart surgery. Lead removal is usually performed in an operating theatre with a cardiac surgeon and team standing by, who can immediately perform emergency surgery.
When is another pacemaker or defibrillator implanted to replace the one removed?
This depends on the reason for removal and the dependence of the patient on the pacemaker. Some patients cannot live without a pacemaker so a "temporary pacing wire" has to be inserted through a vein in the groin or the neck, before the permanent pacemaker and leads can be removed. A new pacemaker is then implanted several days later. Some other patients can get by without a pacemaker for several days or weeks and so the new pacemaker implant can be delayed. Sometimes a pacemaker or defibrillator is no longer needed.
Many people have surgically implanted cardiac devices. These devices include pacemakers and implantable cardioverter defibrillators or ICDs. Pacemakers can help treat slow heart rhythms, and ICDs stop dangerous rapid heart rhythms.
Both these devices have 2 main components: a pulse generator and a set of leads. The pulse generator is a small computer with electric circuits and a battery. The leads are wires that run between the pulse generator and the heart. These leads can deliver a burst of energy in both pacemakers and ICDs. This burst of energy can cause the heart to beat more quickly (in a pacemaker), or it can stop dangerous rapid heart rhythms (in an ICD). To do this, the leads need to contact the heart itself. Most leads travel through a vein to enter the right side of the heart. They usually connect to the inside of the heart with a small screw screwed directly into the muscle of the heart wall. The body forms scar tissue around the lead, which anchors it even more firmly to the heart.
The design of the leads allows them to stay attached to the heart permanently. Sometimes, however, it is necessary to remove leads. This is called lead extraction. The surgeon opens the area where the leads are attached to the pulse generator and disconnects the leads. Laser or mechanical sheaths are then placed over the leads to free them from the body. This allows the leads to be removed safely from the body.
Now in this case, it is not clear that whether there was need of lead extraction from the device. If it was so, it was the duty of the surgeon tell the patient or his family members. The pacemaker is not removed. After expiry of the life of battery it is replaced by another one. Before commission of funeral it is removed as discussed above. So in this case we cannot understand the reason of its removal. Is there any report of any cardiologist or there is consent of the patient or his family members to get pacemaker removed because it is most important part to maintain the heart beat normal. This shows deficiency of service and a on the part of the hospital and concerned doctor.It is also surprising that the patient was of more than 60 years of age having pacemaker and the concerned Doctor removed the pacemaker knowing that the patient has angina problem since many years and it is necessary to maintain the heartbeat. Furthermore the pacemaker has been removed without informing the patient and his family members are and also without taking their consent. Here carelessness on the part of the opposite parties is clear.
From the perusal of documents and evidence it is clear that the opposite party did not provide the records regarding the treatment of the patient by the hospital to the family members of the patient to the complainant. Why? It is duty of the hospital to provide all the documents concerning the patient at the time of his death immediately so that there shall be no chance of any manipulation in the records. It is really strange that after the order of the Hon'ble High Court, the concerned documents were delivered and still as per complainants version, many documents have not been delivered for which the contempt application has already been moved before the Hon'ble High Court. The hospitals are not muscles men. If you are properly treating a patient, in case of his death or at the time of discharge it is your duty to provide all the documents to him regarding his treatment. And if it not given at the time of discharge, and adverse inference shall be drawn regarding manipulation of the records.
No specific document regarding taking consent of the patient or his family members for angiography or any other serious treatment has been filed . The opposite parties have stated in the written statement that the consent for angiography was also taken as would be clear from perusal of the document. We have seen the concerned document regarding consent. It is a printed pro forma on which everything is printed. In this consent form it has been written though the form is not very clear and legible but it shows that the consent has been taken for diagnostic examination....Any session of contrast dye and radioisotopes, biopsy, transfusion, operation and.... of any anaesthesia as may deem & advisable in the course of this hospital admission/..... And no responsible will be attributed to the treating doctor or any other hospital staff. I also give my full consent to conduct post-mortem examination if, it is found necessary for establishing proper diagnosis leading to enhancement of knowledge in medical field. It is really surprising that the consent has been taken even for post-mortem examination of the body for the purpose of education for the medical students. Also so many consents for so many activities have been taken in a single consent form. Whether it is proper and according to the well-established routes and pro forma regarding taking consent ? We are taken an article from the Internet which is reproduced here.
Consent and the Indian medical practitioner Ajay Kumar, Parul Mullick, Smita Prakash and Aseem BharadwajAuthor information Copyright and License information Disclaimer.
This article has been cited by other articles in PMC.
Abstract Consent is a legal requirement of medical practice and not a procedural formality. Getting a mere signature on a form is no consent. If a patient is rushed into signing consent, without giving sufficient information, the consent may be invalid, despite the signature. Often medical professionals either ignore or are ignorant of the requirements of a valid consent and its legal implications. Instances where either consent was not taken or when an invalid consent was obtained have been a subject matter of judicial scrutiny in several medical malpractice cases. This article highlights the essential principles of consent and the Indian law related to it along with some citations, so that medical practitioners are not only able to safeguard themselves against litigations and unnecessary harassment but can act rightfully.
INTRODUCTION Legally, two or more persons are said to consent when they agree upon the same thing in the same sense.[1] Consent must be obtained prior to conducting any medical procedure on a patient. It may be expressed or implied by patient's demeanour. A patient who comes to a doctor for treatment implies that he is agreeable to general physical (not intimate) examination.[2] Express consent (verbal/written) is specifically stated by the patient. Express verbal consent may be obtained for relatively minor examinations or procedures, in the presence of a witness.[3] Express written consent must be obtained for all major diagnostic, anaesthesia and surgical procedures as it is the most undisputable form of consent.
ESSENTIAL PRINCIPLES OF A VALID CONSENT AND THE INDIAN LAW A doctor must take the consent of the patient before commencing a treatment/procedure except in emergencies, informed consent should be obtained sometime prior to the procedure so that the patient does not feel pressurised or rushed to sign. On the day of surgery, the patient may be under extreme mental stress or under influence of pre-medicant drugs which may hamper his decision-making ability. Consent remains valid for an indefinite period, provided there is no change in patient condition or proposed intervention.[4] It should be confirmed at the time of surgery.[4] Consent must be taken from the patient himself.
The doctor before performing any procedure must obtain patient's consent.[5] No one can consent on behalf of a competent adult. In Dr. Ramcharan Thiagarajan Facs versus Medical Council of India case,[6] disciplinary action was awarded to the surgeon for not taking a proper informed consent for the entire procedure of kidney and pancreas transplant surgery from the patient. In some situations, beside patient consent, it is desirable to take additional consent of spouse. In sterilisation procedures, according to the Ministry of Health and Family Welfare, Government of India guidelines, consent of spouse is not required.[7] The Medical Council of India (clause 7.16) however states that in case an operation carries the risk of sterility, the consent of both husband and wife is needed.[8] It is advisable to take consent of spouse when the treatment or procedure may adversely affect or limit sex functions, or result in death of an unborn child.[9] In case of minor, consent of person with parental responsibility should be taken.[10] In an emergency, the person in charge of the child at that time can consent in absence of parents or guardians (loco parentis).[11] In a medical emergency, life-saving treatment can be given even in absence of consent.
Refusing treatment in life-threatening situations due to non-availability of consent may hold the doctor guilty, unless there is a documented refusal to treatment by the patient. In Dr. TT Thomas versus Smt. Elisa and Orscase,[12] the doctor was held guilty of negligence for not operating on a patient with life-threatening emergency condition, as there was no documented refusal to treatment.
The patient should have the capacity and competence to consent.
A person is competent to contract[13] if (i) he has attained the age of majority,[14] (ii) is of sound mind[15] and (iii) is not disqualified from contracting by any law to which he is subject. The legal age for giving a valid consent in India is 18 years.[14] A child >12 years can give a valid consent for physical/medical examination (Indian Penal Code, section 89).[3] Prior to performing any procedure on a child <18 years, it is advisable to take consent of a person with parental responsibility so that its validity is not questioned. If patient is incompetent, then consent can be taken from a surrogate/proxy decision maker who is the next of kin (spouse/adult child/parent/sibling/lawful guardian).[11] Consent should be free and voluntary.
Consent is said to be free[16] when it is not caused by coercion,[17] undue influence,[18] fraud,[19] misrepresentation,[20] or mistake.[21,22,23] Consent should be informed.
Consent should be on the basis of adequate information concerning the nature of the treatment procedure.[5] Consent should be informed and based on intelligent understanding. The doctor must disclose information regarding patient condition, prognosis, treatment benefits, adverse effects, available alternatives, risk of refusing treatment and the approximate treatment cost. He should encourage questions and answer all queries.[2] If the possibility of a risk, including the risk of death, due to performance of a procedure or its refusal is remote or only theoretical, it need not be explained.[5] Exceptions to physician's duty to disclose include[24] : (i) Patient refusal to be informed; this should be documented. (ii) If the doctor feels that providing information to a patient who is anxious or disturbed would not be processed rationally by him and is likely to psychologically harm him, the information may be withheld from him (therapeutic privilege); he should then communicate with patient's close relative, family doctor or both.
The "adequate information" must be furnished by the doctor (or a member of his team) who treats the patient.[5] Information imparted should enable the patient to make a balanced judgment as to whether he should submit himself to the particular treatment or not.[5] Consent should be procedure specific.
Consent given only for a diagnostic procedure, cannot be considered as consent for the therapeutic treatment.[5] Consent given for a specific treatment procedure will not be valid for conducting some other procedure.[5] In Samira Kohli versus Dr. Prabha Manchanda and Anr case,[5] the doctor was held negligent for performing an additional procedure on the patient without taking her prior consent. An additional procedure may be performed without consent only if it is necessary to save the life or preserve the health of the patient and it would be unreasonable to delay, until patient regains consciousness and takes a decision.[5] A common consent for diagnostic and operative procedures may be taken where they are contemplated.[5] Consent obtained during the course of surgery is not acceptable.
In Dr. Janaki S. Kumar and Anr. versus Mrs. Sarafunnisacase,[25] in an allegation of performing sterilisation without consent, it was contended that consent was obtained during the course of surgery. The commission held that the patient under anaesthesia could neither understand the risk involved nor could she give a valid consent.
Consent for blood transfusion.
When blood transfusion is anticipated, a specific written consent should be taken,[24] exception being an emergency situation where blood transfusion is needed to save life and consent cannot be attempted.[26] In M. Chinnaiyan versus Sri. Gokulam Hospital and Anrcase,[27] court awarded compensation as patient was transfused blood in the absence of specific consent for blood transfusion.
Consent for examining or observing a patient for educational purpose Prior to examining or observing patients for educational purpose, their consent must be taken.[28] Blanket consent is not valid.
Consent should be procedure specific. An all-encompassing consent to the effect 'I authorize so and so to carry out any test/procedure/surgery in the course of my treatment' is not valid.[29] Fresh consent should be taken for a repeat procedure.
A fresh written informed consent must be obtained prior to every surgical procedure that includes re-exploration procedure. In Dr. Shailesh Shah versus AphraimJayanand Rathod case,[30] the surgeon was found deficient in service and was liable for compensation as he had performed a re-exploration surgery without a written consent from the patient.
Surgical consent is not sufficient to cover anaesthesia care.
The surgeons are incapable to discuss the risks associated with anaesthesia. Informed consent for anaesthesia must be taken by the anaesthesia provider as only he can impart anaesthesia related necessary information and explain the risks involved. It may be documented by the anaesthesiologist on the surgical consent form by a handwritten note, or on a separate anaesthesia consent form.[31] Patient has the right to refuse treatment.
Competent patients have the legal and moral right to refuse treatment, even in life-threatening emergency situations.[31] In such cases informed refusal must be obtained and documented, over the patient's witnessed signature.[32] It may be advisable that two doctors document the reason for non-performance of life-saving surgery or treatment as express refusal by the patient or the authorised representative and inform the hospital administrator about the same.
To detain an adult patient against his will in a hospital is unlawful.[9] If a patient demands discharge from hospital against medical advice, this should be recorded, and his signature obtained.[9] Unilaterally executed consents are void.
Consent signed only by the patient and not by the doctor is not valid.[33] Witnessed consents are legally more dependable.
The role of a witness is even more important in instances when the patient is illiterate, and one needs to take his/her thumb impression.[34] Consent should be properly documented Video-recording of the informed consent process may also be done but with a prior consent for the same. This should be documented. It is commonly done for organ transplant procedures. If consent form is not signed by the patient or is amended without his signed authorisation, it can be claimed that the procedure was not consented to.[10] Patient is free to withdraw his consent anytime.
When consent is withdrawn during the performance of a procedure, the procedure should be stopped. The doctor may address to patient's concerns and may continue the treatment only if the patient agrees. If stopping a procedure at that point puts patient's life in danger, the doctor may continue with the procedure till such a risk no longer exists.[10] Consent for illegal procedures is invalid.
There can be no valid consent for operations or procedures which are illegal.[24] Consent for an illegal act such as criminal abortion is invalid.[9] Consent is no defence in cases of professional negligence.[9] HOW TO OBTAIN A VALID CONSENT AND CONSENT FORMAT.
Always maintain good communication with your patient and provide adequate information to enable him make a rational decision.[35] It is preferable to take consent in patient's vernacular language. It may be better to make him write down his consent in the presence of a witness.[34] It is desirable to use short and simple sentences and non-medical terminology that is written/typed legibly.[36] Patient information sheets (PIS) depicting procedure related information, including pre-operative and post-operative pre-cautions in patient's understandable local language with pictorial representation may facilitate the informed consent process. These may help in providing consistently accurate information to the patients.[35] PIS should be handed over to the patients after explaining the contents. Even videos may be used as an aid in increasing patient understanding.[37] Though there is no standard consent format, it may include the following [e.g., Figure 1]:[38] Figure 1 Anaesthesia informed consent form Document the fact that patient and relatives were allowed to ask questions, and their queries were answered to their satisfaction.
CONSENT IN RELATION TO PUBLICATION.
A registered medical practitioner is not permitted to publish photographs or case reports of his/her patients without their consent, in any medical or another journal in a manner by which their identity could be revealed. However, in case the identity is not disclosed, consent is not needed (clause 7.17).[8] CONSENT IN RELATION TO MEDICAL RESEARCH Consent taken from the patient for the drug trial or research should be as per the Indian Council of Medical Research guidelines[39]; otherwise it shall be construed as misconduct (clause 7.22).[8] COMMON FALLACIES IN THE CONSENT PROCESS.
The anaesthesiologist must ensure that consent is given maximum importance, and all the legal formalities are followed before agreeing to provide the services. Following are some frequent mistakes and omissions that can cost him/her dearly in the event of a mishap:Procedure is considered trivial, and consent is not taken.
Consent of relative is taken instead of the patient, even when patient is a competent adult.
Consenting person is minor, intoxicated or of unsound mind Blanket consent is taken.
Date and time Patient related: Name, age and signature of the patient/proxy decision maker Doctor related: Name, registration number and signature of the doctor Witness: Name and signature of witness Disease-related: Diagnosis along with co-morbidities if any Surgical procedure related: Type of surgery (elective/emergency), nature of surgery with antecedent risks and benefits, alternative treatment available, adverse consequences of refusing treatment Anaesthesia related: Type of anaesthesia (general and/or regional, local anaesthesia, sedation) including risks Blood transfusion: Requirement and related risks Special risks: Need for post-operative ventilation, intensive care, etc Alterations or additions are made in the consent form without patient's signed authorisation.
It is not procedure specific Consent for blood transfusion is not obtained.
Fresh consent is not taken for a repeat procedure Procedure related necessary information is not given Even if the information given, it is not documented Consent lacks the signature of the treating doctor Consent is not witnessed SUMMARY It is not only ethical to impart correct and necessary information to a patient prior to conducting any medical procedure, but it is also important legally. This communication should be documented. Even professional indemnity insurance may not cover for lapses in obtaining a valid consent, considering it to be an intentional assault.
ACKNOWLEDGMENTS We gratefully acknowledge the invaluable contribution and irreplaceable advice extended to us during the preparation of this article by Mr. M Wadhwani, Advocate.
[ REFERENCES
1. Indian Contract Act, Sec 13; 1872. [Accessed on 2014 Aug 21]. Available from: http://www.indianlawcases.com/Act-Indian.Contract.Act,1872.-2386 .
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39. Ethical Guidelines for Biomedical Research on Human Participants. New Delhi: Published by: Director General Indian Council of Medical Research; 2006. [Accessed on 2014 Mar 3]. eral Ethical Issues; pp. 21-33. ] Now we discuss a little about consent form filed by the opposite parties as annexure -2with his written statement. First there is no signature of the concerned Dr on this consent form. There is no separate consent form for anaesthesia. This pro forma is not in accordance with the pro forma prescribed for taking the consent. There is no separate consent to use the body for post-mortem examination for the purpose of study. There is nothing in this consent form which show that the doctor has specifically mentioned all the risks to the patient or his family members regarding angiographyor any other tests which may be performed. So this consent form is not a proper consent form as per the guidelines. It also shows deficiency and negligence on the part of the opposite parties.
Now let us see the oath taken be a doctor before entering the nobel profession of the Medical World. As per guidelines of MCI, Every member should get it framed in his or her office it should never be violated in its letter and spirit.
"I solemnly pledge myself to consecrate my life to service of humanity.
Even under threat, I will not use my medical knowledge contrary to the laws of Humanity.
I will maintain the utmost respect for human life from the time of conception.
I will not permit considerations of religion, nationality, race, party politics or social standing to intervene between my duty and my patient.
I will practice my profession with conscience and dignity.
The health of my patient will be my first consideration.
I will respect the secrets which are confined in me.
I will give to my teachers the respect and gratitude which is their due.
I will maintain by all means in my power, the honour and noble traditions of medical profession.
I will treat my colleagues with all respect and dignity.
I shall abide by the code of medical ethics as enunciated in the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations 2002.
I make these promises solemnly, freely and upon my honour."
The complexity of the human body and the uncertainty involved in the medical procedure are of such great magnitude that it is impossible for a Doctor to guarantee a successful result; and the only assurance that he can give, or can be understood to have given by implication is that he is possessed of requisite skill in that branch of profession which he is practising and while undertaking the performance of the task entrusted to him, he would be exercising his skills with reasonable competence. An ordinary physician or surgeon is not expected to be either a clodhopper or feckless practitioner of profession, as much as, he is not expected to be a paragon, combining qualities of polymath or prophet as in the realm of diagnosis and treatment, there is ample scope for genuine difference of opinion; and a Doctor cannot be treated as negligent merely because his conclusion differs from that of other persons in the profession, or because he has displayed less skill or knowledge than others would have shown. The true test for establishing negligence in diagnosis or treatment on the part of a doctor is whether he has been proved to be guilty of such failure as no doctor of ordinary skill would be guilty of, if acting with ordinary care. Furthermore, a golden principle of law has been laid down by the Hon'ble Apex Court in Jacob Mathew Vs. State of Punjab, (AIR 2005 SC 3180) that no sensible professional would intentionally commit an act or omission which would result in loss or injury to the patient as the professional reputation of the person is at stake. A single failure may cost him dear in his career. Even in civil jurisdiction, the rule of res ipsa loquitor is not an universal application and has to be applied with extreme care and caution to the cases of professional negligence and in particular that of the doctors, else it would be counter productive. Simply because a patient has not favourably responded to a treatment given by a physician or a surgery has failed, the doctor cannot be held liable per-se by applying the doctrine of res ipsa loquitor. Yet, another golden principle of law has been laid down by the Hon'ble Apex Court in Indian Medical Association Vs. V.P. Santha's III (1995) CPJ 1 (SC) at para 37 that "it is no doubt true that sometimes complicated questions requiring recording of evidence of experts may arise in a complaint about deficiency in service based on the ground of negligence in rendering medical services by a medical practitioner; but this would not be so in all complaints about deficiency rendering services by a medical practitioner. There may be cases which do not raise such complicated questions and the deficiency in service may be due to obvious faults which can be easily established such as removal of the wrong limb or the performance of an operation on the wrong patient or giving injection of a drug to which the patient is allergic without looking into the out patient card containing the warning or use of wrong gas during the course of an anaesthetic or leaving inside the patient swabs or other items of operating equipment after surgery. Furthermore, it has been observed in Malay Kumar Ganguli's case (AIR 2010 SC 1162) that" charge of professional negligence on a medical person is a serious one as it affects his professional statusand reputation and as such, the burden of proof would be more onerous. A doctor cannot be held negligent only because something has gone wrong. He also cannot be held liable for mischance or misadventure or for an error in judgment in making a choice when two options are available. The mistake in diagnosis is not necessarily a negligent diagnosis." In the instant matter, thus a simple test, in the light of aforesaid observations, needs to be conducted in order to ascertain whether the Doctor is guilty of any tortious act of negligence/battery amounting to deficiency in conducting a surgery in the delivery of child and not properly attending the patient, the complainant and consequently, liable to pay damages for leaving cotton mass in the abdomen / stomach due to failure in surgery and deteriorating condition of the patient.
Now, it is required to be seen whether an expert report is necessary in each and every case relating to medical negligence or not ? It has been observed by the Hon'ble Apex Court in Indian Medical Association Vs. V.P. Santha III (1995) CPJ 1 (SC) at para 37 that "it is no doubt true that sometimes complicated questions requiring recording of evidence of experts may arise in a complaint about deficiency in service based on the ground of negligence in rendering medical services by a medical practitioner; but this would not be so in all complaints about deficiency rendering services by a medical practitioner. There may be cases which do not raise such complicated questions and the deficiency in service may be due to obvious faults which can be easily established such as removal of the wrong limb or the performance of an operation on the wrong patient or giving injection of a drug to which the patient is allergic without looking into the out patient card containing the warning or use of wrong gas during the course of an anaesthetic or leaving inside the patient swabs or other items of operating equipment after surgery. Furthermore, in B. Krishna Rao Vs. Nikhil Super Speciality Hospital 2010 (V) SCC513 at para 40 the Hon'ble Apex Court was pleased to hold that it is not necessary to have opinion of the expert in each and every case of medical negligence. The Hon'ble Apex Court was pleased to further hold in Nizam Institute of Medical Sciences Vs. Prashant S. Dhananka and others 2009 (VI) SCC 1 that "in a case of medical negligence, once initial burden has been discharged by the complainant by making of a case of negligence on the part of the hospital or the doctor concerned, the owner then shifts on the hospital or to the attending doctors and it is for the hospital to satisfy the court that there was no lack of care or diligence".
A doctrine or rule of evidence in tort law that permits an inference or presumption that a defendant was negligent in an accident injuring the plaintiff on the basis of circumstantial evidence if the accident was of a kind that does not ordinarily occur in the absence of negligencea plaintiff who establishes the elements of res ipsa loquitur can withstand a motion for summary judgment and reach the jury without direct proof of negligence-- Cox v. May Dept. Store Co., 903 P.2d 1119 (1995).
In Byrne vs Boadle, this maxim was used for the first time where the complainant was injured by a barrel that dropped from the window of the defendant. In the abovementioned case, Pollock, C. B., said "here are many incidents from which no presumption of negligence can arise, but this is not true in every case. It is the duty of persons who keep barrels in a warehouse to take care that they do not roll out and I think that such a case will, beyond all doubt, afford prima facie proof of negligence."
This doctrine intends to help direct the court proceedings to a conclusion, especially if it is established through the implication of this doctrine's rule that the injury caused to the claimant would not have occurred or taken place if the defendant wasn't negligent.This also gives enough cause and evidence to hold the defendant liable for his negligent actions.
The thing speaks for itselfis the gist of the maxim Res Ipsa Loquitur Maxim. What are the essentials of this maxim.
The injury caused to the plaintiff shall be a result of an act of negligence.
There is a lack of evidence, or the evidence presented before the court is insufficient to establish the possibilities of the fault of the plaintiff or third party.
The defendant owes a duty of care towards the plaintiff, which he has breached.
There is a significant degree of injury caused to the plaintiff.
Applicability of Doctrine of Res Ipsa Loquitur.
The maxim of res ipsa loquitur came into force to benefit the plaintiff as he can use circumstantial evidence to establish negligence.
Consequently, it shifts the burden of proof on the defendant, logic being, where there is an event of unexplained cause, usually, the one that does not occur without the defendant's negligence in controlling the action which has caused the injury to the claimant or destroyed his goods.
In this scenario, the court shall presume negligence on the part of the defendant in such a case unless it includes an appropriate explanation compatible with his taking reasonable care.
In AchutraoHaribhauKhodwa and Others vs. State of Maharashtra and Others, it was considered that the maxim should not be applied in the case of general incidences of neglect and shall only be reflected when there is a significant degree of injury caused.
Section 106 of the Indian Evidence Act Section 106 of the Act provides that when any fact is especially within the knowledge of any person, the burden of proving that fact is upon him.
Res ipsa loquitur is a Latin phrase that means "the thing speaks for itself." In personal injury law, the concept of res ipsa loquitur (or just "res ipsa" for short) operates as an evidentiary rule that allows plaintiffs to establish a rebuttable presumption of negligence on the part of the defendant through the use of circumstantial evidence.
This means that while plaintiffs typically have to prove that the defendant acted with a negligent state of mind, through res ipsa loquitur, if the plaintiff puts forth certain circumstantial facts, it becomes the defendant's burden to prove he or she was not negligent.
Res Ipsa Loquitur and Evidence Law Accidents happen all the time, and the mere fact that an accident has occurred doesn't necessarily mean that someone's negligence caused it. In order to prove negligence in a personal injury lawsuit, a plaintiff must present evidence to demonstrate that the defendant's negligence resulted in the plaintiff's injury. Sometimes, direct evidence of the defendant's negligence doesn't exist, but plaintiffs can still use circumstantial evidence in order to establish negligence.
Circumstantial evidence consists of facts that point to negligence as a logical conclusion rather than demonstrating it outright. This allows judges and juries to infer negligence based on the totality of the circumstances and the shared knowledge that arises out of human experience. Res ipsa is one type of circumstantial evidence that allows a reasonable fact finder to determine that the defendant's negligence caused an unusual event that subsequently caused injury to the plaintiff.
This doctrine arose out of a case where the plaintiff suffered injuries from a falling barrel of flour while walking by a warehouse. At the trial, the plaintiff's attorney argued that the facts spoke for themselves and demonstrated the warehouse's negligence since no other explanation could account for the cause of the plaintiff's injuries.
As it has developed since then, res ipsa allows judges and juries to apply common sense to a situation in order to determine whether or not the defendant acted negligently.
Since the laws of personal injury and evidence are determined at the state level, the law regarding res ipsa loquitur varies slightly between states. That said, a general consensus has emerged, and most states follow one basic formulation of res ipsa.
Under this model for res ipsa, there are three requirements that the plaintiff must meet before a jury can infer that the defendant's negligence caused the harm in question:
The event doesn't normally occur unless someone has acted negligently;
The evidence rules out the possibility that the actions of the plaintiff or a third party caused the injury; and The type of negligence in question falls with the scope of the defendant's duty to the plaintiff.
As mentioned above, not all accidents occur because of someone else's negligence. Some accidents, on the other hand, almost never occur unless someone has acted negligently.
Going back to the old case of the falling flour-barrel, it's a piece of shared human knowledge that things don't generally fall out of warehouse windows unless someone hasn't taken care to block the window or hasn't ensured that items on the warehouse floor are properly stored. When something does fall out of a warehouse window, the law will assume that it happened because someone was negligent.The second component of a res ipsa case hinges on whether the defendant carries sole responsibility for the injury. If the plaintiff can't prove by a preponderance of the evidence that the defendant's negligence cause the injury, then they will not be able to recover under res ipsa.
States sometimes examine whether the defendant had exclusive control over the specific instrumentality that caused the accident in order to determine if the defendant's negligence caused the injury. For example, if a surgeon leaves a sponge inside the body of a patient, a jury can infer that the surgeon's negligence caused the injury since he had exclusive control over the sponges during the operation.
In addition to the first two elements, the defendant must also owe a duty of care to protect the plaintiff from the type of injury at issue in the suit. If the defendant does not have such a duty, or if the type of injury doesn't fall within the scope of that duty, then there is no liability.
For example, in many states, landowners don't owe trespassers any duty to protect them against certain types of dangers on their property. Thus, even if a trespasser suffers an injury that was caused by the defendant's action or inaction and that wouldn't normally occur in the absence of negligence, res ipsa loquitur won't establish negligence since the landowner never had any responsibility to prevent injury to the trespasser in the first place.
Res ipsa only allows plaintiffs to establish the inference of the defendant's negligence, not to prove the negligence completely. Defendants can still rebut the presumption of negligence that res ipsa creates by refuting one of the elements listed above.
For example, the defendant could prove by a preponderance of the evidence that the injury could occur even if reasonable care took place to prevent it. An earthquake could shake an item loose and it could fall out of the warehouse window, for instance.
A defendant could also demonstrate that the plaintiff's own negligence contributed to the injury. To go back to the flour-barrel example, if the defendant shows that the plaintiff was standing in an area marked as dangerous it could rebut the presumption of negligence created by res ipsa.
Finally, the defendant could establish that he did not owe the plaintiff a duty of care under the law, or that the injury did not fall within the scope of the duty owed. For example, if the law only imposes a limited duty on the defendant not to behave recklessly, then res ipsa will not help the plaintiff by creating an inference of negligence since a negligent action would not violate the duty owed to the plaintiff.
According to the Blacks Law Dictionary the maxim is defined as the doctrine providing that, in some circumstances, the mere fact of accidents occurrence raises an inference of negligence so as to establish a prima facie (at first sight) case. It is a symbol for that rule that the fact of the occurrence of an injury taken with the surrounding circumstances may permit an inference or recipes omission of negligence, or make out a plaintiff's prima facie case and present a question of fact for defendant to meet with and explanation. It is merely a short way of saying that the circumstances attendant on the accident are of such a nature to justify a jury in light of common sense and past experience in inferring that the accident was probably the result of the defendant's negligence, in the absence of explanation or other evidence which the jury believes.
Its use in clinical negligence gained some traction before Bolam and Bolitho. Mahon v Osborne [1939] 1 All ER 535, is an early example of the application of res ipsa loquitur in a case where a surgical swab had been left inside a patient's body.
In Clarke v Worboys (1952) Times, 18 March, CA, a patient noticed burns on her buttock shortly after surgical excision of a breast tumour. The surgery involved cauterisation. The Court of Appeal held that this was a case where res ipsa loquitur applied. The outcome was not one that would ordinarily occur in the absence of negligence, and the surgical team were unable to explain how the injury was caused.
In Cassidy v Ministry of Health [1951] 2 KB 343, Denning LJ succinctly summarised the maxim's application to clinical negligence cases: "I went into hospital to be cured of two stiff fingers. I have come out with four stiff fingers and my hand is useless. That should not happen if due care had been used. Explain it if you can."
Ng Chun Pui Vs Lee Chuen Tat, the first defendant was driving a coach owned by the second defendant westwards in the outer lane of dual carriageway in Hong Kong. Suddenly the course across the central reservation and collided with a public bus travelling in the inner lane of the other carriageway, killing one passenger in the bus and injuring the driver and three others on the bus. The plaintiff could not prove that the defendants were negligent and had caused the accident. They however proceeded on the basis of Res Ipsa Loquitur and shifted the onus on the defendants to prove that they were not negligent. However, they failed to do so. And the judicial committee of the Privy Council held the defendants liable for the plaintiffs injuries. { MarkLuney and Ken Opliphant, Tort Law Text And Materials (Oxford University Press, New York, 2000) pp 173-175 } In A.S. Mittal &Anr Vs State Of UP &Ors , AIR 1979 SC 1570 , the defendants had organised an eye camp at Khurja along with the Lions Club. 88 low risk cataract operations were undertaken during the period of the camp. It was however, disastrous as many of those who had been operated upon lost their eyesight due to post medical treatment. Proceedings against the government initiated for negligence of the doctors. Damages worth Rs.12,500/- were paid as interim belief to each of the aggrieved. The decision was on the basis of Res Ipsa Loquitur as the injury would not ave occurred had the doctors not been negligent in not having followed up with post-operation treatment. Res Ipsa Loquitur can be applied in matters where are the procedures have not been followed and is not just limited to the commission of an act.
We can define 'Medical negligence' as the improper or unskilled treatment of a patient by a medical practitioner. This includes negligence in taking care from a nurse, physician, surgeon, pharmacist, or any other medical practitioner. Medical negligenceleads to 'Medical malpractices' where the victims suffer some sort of injury from the treatment given by a doctor or any other medical practitioner or health care professional.
Medical negligence can occur in different ways. Generally, it occurs when a medical professional deviates from the standard of care that is required.
So, we can say that any kind of deviation from the accepted standards of medication and care is considered to be medical negligence and if it causes injury to a patient then the doctor who operated on him, other staff and/or hospital may be held liable for this.
Some of the common categories of medical negligence are as follows:
Wrong diagnosis - When someone goes to a hospital, clinic or medical room, etc. the first step after admittance is the diagnosis. Diagnosing symptoms correctly is critical and important to provide medical care to any patient. However, if a patient is not treated properly due to any mistake in diagnosis, the doctor can be made liable for any further injury or damages caused as a result of the wrong diagnosis.
Delay in diagnosis - A delayed diagnosis is treated as medical negligence if another doctor would have reasonably diagnosed the same condition in a timely fashion. A delay in diagnosis can cause undue injury to the patient if the illness or injury is left to worsen with time rather than being treated. Obviously, any delay in the identification and treatment of an injury can reduce the chance of recovery for the patient.
Error in surgery - Surgical operations require an enormous level of skill and it should be done with due care and caution because even the slightest mistakes can have profound effects on the patient. The wrong-site surgery, lacerations of any internal organ, severe blood loss, or a foreign object being left in the body of the patients, all this comes under Surgical error.
Unnecessary surgery - Unnecessary surgery is usually associated with the misdiagnosis of patient symptoms or a medical decision without proper consideration of other options or risks. Alternatively, sometimes surgery is chosen over conventional treatments for their expediency and ease compared to other alternatives.
Errors in the administration of anesthesia - Anesthesia is a risky part of any major medical operation and requires a specialist (anesthesiologist) to administer and monitor its effect on the patient. Prior to any medical procedure requiring anesthesia, the anesthesiologist has to review the patient's condition, history, medications, etc. to determine the most suitable of all the medicine to use. Anesthesia malpractice can happen even during the pre-operation medical review or during the procedure itself.
Childbirth and labor malpractice - Childbirth is a difficult event for a woman and it becomes worse if not handled properly by the doctors and nurses. There are many instances of medical negligence during childbirth including the mishandling of a difficult birth, complications with induced labor, misdiagnosis of a newborn medical condition, etc. Long-Term negligent treatment - Medical negligence can also occur in subtle ways over the course of a long treatment period. Usually, the negligence can take the shape of a failure to follow up with treatment, or a doctor's failure to monitor the effects of the treatment properly.
A standard of care specifies the appropriate treatment and medication procedure as per the requirements that should be taken into account by a doctor while providing the treatment to his patients. The care should not be of the highest degree nor the lowest.Here, the degree means the level of care an ordinary health care professional, with the same training and experience, would render in similar circumstances in the same community. This is the critical question in medical malpractice cases and if the answer is "no," and you suffered injury as a result of the poor treatment, you may file a suit for medical malpractice.
In the case of Dr. Laxman Balkrishna Joshi Vs. Dr. TrimbakBapu Godbole and Anr.[ 1969 AIR 128], the Supreme Court held that a doctor has certain aforesaid duties and a breach of any of those duties can make him liable for medical negligence. A doctor is required to exercise a reasonable degree of care that is set for this profession.
Dr. Kunal Saha vs Dr. Sukumar Mukherjee on 21 October, 2011 ( NC) original petition number 240 OF 1999 is one of the most important case regarding medical negligence. The brief facts of the case are-
Toxic Epidermal Necrolysis ( TEN ) is a rare and deadly disease. It is an extoliative dermatological disorder of unknown cause. A patient with TEN loses epidermis in sheet-like fashion leaving extensive areas or denuded dermis that must be treated like a larze, superficial, partial-thickness burn wound. The incidence of TEN has been reported at 1 to 1.3 per million per year. The female-male ratio is 3:2. TEN accounts for nearly 1% of drug reactions that require hospitalization. TEN has a mortality rate of 25 to 70%.
Smt. Anuradha Saha (in short Anuradha), aged about 36 years wife of Dr. Kunal Saha (complainant) became the unfortunate victim of TEN when she alongwith the complainant was in India for a holiday during April-May 1998. She and the complainant although of Indian original were settled in the United States of America. The complainant is a doctor by profession and was engaged in research on HIV / AIDS for the past fifteen years. Anuradha after acquiring her Graduation and Masters Degree was pursuing a Ph.D. programme in a university of U.S.A. She was a Child Psychologist by profession. Anuradha showed certain symptoms of rashes over her body and received treatment at the hands of Opposite Parties and some other doctors as outdoor patient uptil 10.05.1998 and she was admitted in Advanced Medicare and Research Institute Limited, Calcutta (for short, AMRI), on 11.05.1998, where she was treated by the above-named Opposite Parties and other doctors uptil 16.05.1998. As there was no improvement in her condition, she was shifted to Breach Candy Hospital, Mumbai, on 17.05.1998 by an air ambulance. She was treated in Breach Candy Hospital from 17.05.1998 evening till she breathed her last on 28.05.1998.
Our Complainant as husband of Anuradha felt that the doctors who treated Anuradha and the hospitals where she was treated were grossly negligent in her treatment and her death was occasioned due to gross negligence of the treating doctors and hospitals. Complainant, accordingly, got issued a legal notice to as many as 26 persons i.e. various doctors who treated Anuradha between end of April to the date of her death alleging negligence and deficiency in service on their part and claiming a total compensation exceeding Rs.55 crores from them. Complainant, thereafter filed the present complaint on 09.03.1999 before this Commission claiming a total compensation of Rs. Rs.77,07,45,000/- ( Seventy Seven Crores Seven Lakhs Fourty Five Thousand only). Later he also filed another complaint no. 179 of 2000 in this Commission against Breach Candy Hospital, its doctors and functionaries claiming a further compensation of Rs.25.30 crore ( though the said complaint was later on withdrawn), thereby making claim of compensation exceeding Rs.102 crores, perhaps the highest ever claimed by any complainant for medical negligence before any consumer fora established under the provisions of Consumer Protection Act, 1986 ( in short, the Act). These are some of the facts which make the present case extra ordinary.
The present complaint was filed by the complainant against the above-named opposite parties, namely, Dr. Sukumar Mukherjee, Dr. B. Haldar (Baidyanath Halder), Advanced Medicare and Research Institute Limited ( in short the AMRI Hospital ) and Dr. Balram Prasad and Dr.Abani Roy Chowdhury (physician) and Dr.KaushikNandy (plastic surgeon), the Directors of the AMRI Hospital and others claiming a total compensation of Rs. Rs.77,07,45,000/- under different heads alleging various acts of commission and omission on the part of the doctors and hospital amounting to negligence and deficiency in service. Complainant through his brother-in-law Malay Kumar Ganguly also filed criminal complaint against some of the doctors and the hospital under section 304A IPC.
The complaint was resisted by the doctors and the hospital on a variety of grounds thereby denying any medical negligence or deficiency in service on their part. Parties led voluminous documentary and oral evidence and testimonies of some of the witness were even recorded through video conferencing through a Local Commissioner. After a protracted trial and hearing and on consideration of the evidence and material so produced on record and taking note of the legal position governing the question of medical negligence, this Commission ( by a three Member Bench presided over by the then President) dismissed the complaint by an order dated 01.06.2006 holding as under:
In the result, we reiterate that Doctors or Surgeons do not undertake that they will positively cure a patient. There may be occasions beyond the control of the medical practitioner to cure the patients. From the record, it would be difficult to arrive at the conclusion that the injection Depo-Medrol prescribed by Dr. Mukherjee was of such excessive dose that it would amount to deficiency in service by him which was his clinical assessment.
Thereafter, with regard to the alleged deficiency in the treatment given to Mrs. Anuradha by Opposite Party Doctors 2, 3, 5 and 6, there is no substance. The contention against the hospital that it was not having Burns-Ward, and therefore, the deceased suffered is also without substance. Hence, this complaint is dismissed. There shall be no order as to costs.
Aggrieved by the dismissal of his complaint, the complainant filed Civil Appeal (No.1727 of 2007) in the Honble Supreme Court. It would appear that even before the said appeal was filed before the Hon'ble Supreme Court, the Supreme Court was seized of the matter in Criminal Appeal Nos.1191-94 of 2005 filed by Malay Kumar Ganguly, the complainant in the criminal complaint, against the Orders passed by the Calcutta High Court. Since the Criminal Appeals and the Civil Appeal filed by the complainant in the present complaint raised the same questions of fact and law, the Hon'ble Supreme Court heard all the appeals together and decided the same by means of a detailed judgment dated 07.8.2009. By the said order, the Apex Court dismissed the Criminal Appeals filed by Shri Malay Kumar Ganguly but allowed the Civil Appeal No. 1727 of 2007 filed by the complainant and set aside the order dated 01.6.2006 passed by this Commission dismissing the complaint and remanded the matter to this Commission for the limited purpose of determining the adequate compensation, which the complainant is entitled to receive from the subsisting opposite parties by observing as under:
So far as the judgment of the Commission is concerned, it was clearly wrong in opining that there was no negligence on the part of the Hospital or the doctors. We, are, however, of the opinion, keeping in view the fact that Dr.KaushikNandy has done whatever was possible to be done and his line of treatment meets with the treatment protocol of one of the experts viz.. Prof. Jean Claude Roujeau although there may be otherwise difference of opinion, that he cannot be held to be guilty of negligence.
We remit the case back to the Commission only for the purpose of determination of the quantum of compensation. We, keeping in view the stand taken and conduct of AMRI and Dr. Mukherjee, direct that costs of Rs.5,00,000 and Rs.1,00,000 would be payable by AMRI and Dr. Mukherjee respectively.
We further direct that if any foreign experts are to be examined it shall be done only through video conferencing and at the cost of the respondents.
Summary In view of the foregoing discussion, we conclude as under:
The facts of this case viz., residence of the complainant and Anuradha (deceased) in USA and they working for gain in that country; Anuradha having been a victim of a rare and deadly disease Toxic Epidermal Necrolysis (TEN) when she was in India during April-May 1998 and could not be cured of the said disease despite her treatment at two superspeciality medical centres of Kolkata and Mumbai and the huge claim of compensation exceeding Rs.77 crores made by the complainant for the medical negligence in the treatment of Anuradha makes the present case somewhat extraordinary.
The findings given and observations made by the Supreme Court in its judgment dated 07.08.2009 are absolutely binding on this Commission not only as ratio decidendi but also as obiter dicta also, the judgment having been rendered by the Supreme Court in appeal against the earlier order passed by a three Member Bench of this Commission and, therefore, no attempt can be allowed to read down / dilute the findings and observations made by the Supreme Court because the Supreme Court has remitted the complaint to this Commission only for the purpose of determination of the quantum of compensation after recording the finding of medical negligence against the opposite parties and others.
The task entrusted to the Commission may appear to be simple but the facts of the present case and the voluminous evidence led on behalf of the complainant has made it somewhat arduous. Still difficult was the task of apprortionment of the liability to pay the awarded amount by the different opposite parties and perhaps it was for this reason that the Supreme Court has remitted the matter to this Commission.
Multiplier method provided under the Motor Vehicles Act for calculating the compensation is the only proper and scientific method for determination of compensation even in the cases where death of the patient has been occasioned due to medical negligence / deficiency in service in the treatment of the patient, as there is no difference in legal theory between a patient dying through medical negligence and the victim dying in industrial or motor accident. The award of lumpsum compensation in cases of medical negligence has a great element of arbitrariness and subjectivity.
The foreign residence of the complainant or the patient and the income of the deceased patient in a foreign country are relevant factors but the compensation awarded by Indian Fora cannot be at par which are ordinarily granted by foreign courts in such cases. Socio economic conditions prevalent in this country and that of the opposite parties / defendants are relevant and must be taken into consideration so as to modulate the relief. A complainant cannot be allowed to get undue enrichment by making a fortune out of a misfortune. The theoretical opinion / assessment made by a Foreign Expert as to the future income of a person and situation prevalent in that country cannot form a sound basis for determination of future income of such person and the Commission has to work out the income of the deceased having regard to her last income and future prospects in terms of the criteria laid down by the Supreme Court.
There exists no straight jacket formula for apportionment of the awarded compensation amongst various doctors and hospitals when there are so many actors who are responsible for negligence and the apportionment has to be made by evolving a criteria / formula which is just going by the nature and extent of medical negligence and deficiency in service established on the part of different doctors and hospitals.
On a consideration of the entirety of the facts and circumstances, evidence and material brought on record, we hold that overall compensation on account of pecuniary and non pecuniary damages works out to Rs.1,72,87,500/- in the present case, out of which we must deduct 10% amount on account of the contributory negligence / interference of the complainant in the treatment of Anuradha. That will make the net payable amount of compensation to Rs.1,55,58,750/- (rounded ofto Rs.1,55,60,000/-). From this amount, we must further deduct a sum of Rs.25,93,000/- which was payable by Dr. Abani Roy Chowdhury (deceased) or his Legal Representative as the complainant has forgone the claim against them.
In view of the peculiar facts and circumstances of the case and as a special case, we have awarded a sum of Rs. 5,00,000/- as cost of litigation in the present proceedings.
The above amount shall be paid by opposite parties no.1 to 4 to the complainant in the following manner:
Dr. Sukumar Mukherjee-opposite party no.1 shall pay a sum of Rs.40,40,000/- (Rupees Forty Lakh Forty Thousand only) i.e. [Rs.38,90,000/- towards compensation and Rs.1,50,000/- as cost of litigation].
Dr. B. Haldar (Baidyanth Halder)-opposite party no.2 shall pay a sum of Rs.26,93,000/- (Rupees Twenty Six Lakh Ninety Three Thousand only) i.e. [Rs.25,93,000/- towards compensation and Rs.1,00,000/- as cost of litigation] AMRI hospital-opposite party no.3 shall pay a sum of Rs.40,40,000/- (Rupees Forty Lakh Forty Thousand only ) i.e. [Rs.38,90,000/- towards compensation and Rs.1,50,000/- as cost of litigation .
(iv) Dr. Balram Prasad-opposite party no.4 shall pay a sum of Rs.26,93,000/- (Rupees Twenty Six Lakh Ninety Three Thousand only) i.e. [Rs.25,93,000/- towards compensation and Rs.1,00,000/- as cost of litigation] The opposite parties are directed to pay the aforesaid amounts to the complainant within a period of eight weeks from the date of this order, failing which the amount shall carry interest @ 12% p.a. w.e.f. the date of default.
Immediate postoperative care:
Now an action arises whether there was proper post-operative care taken by the opposite parties after the angiography and after the complication developed in the body of the patient.
Postoperative patients must be monitored and assessed closely for any deterioration in condition and the relevant postoperative care plan or pathway must be implemented.
The NCEPOD (2011) report found that patients whose condition was deteriorating were not always identified and referred for a higher level of care. Patients should be made ascomfortable as possible before postoperative checks are performed.
Postoperative patients are at risk of clinical deterioration, and it is vital that this is minimised. Knowledge and understanding of the key areas of risk and local policies will help reduce potential problems (National Patient Safety Agency, 2007; National Institute for Health and Clinical Excellence, 2007).
Track and trigger or early warning systems are widely used in the UK to identify deteriorating patients. These have been adapted by trusts for adults and children and are based on the patient's pulse and respiratory rate, systolic blood pressure, temperature and level of consciousness. Additional monitoring may include pain assessment, capillary refill time, percentage of oxygen administered, oxygen saturation, central venous pressure, infusion rates and hourly urine output.
The National Early Warning Score (NEWS) was developed by a working party to provide a national standard for assessing, monitoring and tracking acutely and critically ill patients (not for use with children under 16 years or in pregnancy); the intention was that trusts would use it to replace their locally adapted early warning systems (Royal College of Physicians, 2012). Like other early warning systems, NEWS has six physiological parameters:
Respiratory rate;
Oxygen saturation;
Temperature;
Systolic blood pressure;
Pulse rate;
Level of consciousness (this will be impaired in patients who have had recent sedation or are receiving opioid analgesia, which should be taken into consideration in assessment).
The system also includes a weighting score of two, which is added if the patient is receiving supplemental oxygen via a mask or nasal cannulas.
When assessing the postoperative patient using NEWS, it is vital that the patient is observed for signs of haemorrhage, shock, sepsis and the effects of analgesia and anaesthetic. Patients receiving intravenous opiates are at risk of their vital signs and consciousness levels being compromised if the rate of the infusion is too high. It is therefore imperative that the patient's pain control is managed well, initially by the anaesthetist and then the ward staff and pain team or anaesthetist, to ensure that the patient has adequate analgesia but is alert enough to be able to communicate and cooperate with clinical staff in the postoperative period.
Many trusts have yet to implement NEWS, although it is beginning to be taught in pre-registration nursing programmes. Student nurses frequently perform postoperative observations under the supervision of a nurse; it is reassuring that they receive some insight and education as recommended by NCEPOD (2011).
Vital signs;
Vital signs should be performed in accordance with local policies or guidelines and compared with the baseline observations taken before surgery, during surgery and in the recovery area.
Nurses should also be aware of the parameters for these observations and what is normal for the patient under observation. When assessing patients' recovery from anaesthesia and surgery, these observations should not be considered in isolation; the nurse should look at and feel the patient. This also applies to children and should include observation of other signs and symptoms, for example abdominal tenderness or poor urine output, which could indicate deterioration (Royal College of Nursing, 2011). The RCN (2011) provides guidance on vital signs performed post-operatively on children. Many trusts now insist that vital signs are performed manually to provide more accurate recording and assessment.
All vital signs and assessments should be recorded clearly in accordance with guidelines for record keeping (Nursing and Midwifery Council, 2009). Handheld personal digital assistants (PDAs) are used at some trusts to store track and trigger data and calculate early warning scores, which can be accessed by the clinical and outreach teams.
When a patient's condition is identified as deteriorating, this information can be passed verbally to appropriate health professionals using the Situation, Background, Assessment and Recommendation (SBAR) tool advocated by the NHS Institute for Innovation and Improvement (2008).
Airway and respirations Respiratory rate and function is often the first vital sign to be affected if there is a change in cardiac or neurological state. It is therefore imperative that this observation is performed accurately; however, studies show it is often omitted or poorly assessed (NPSA, 2007; NCEPOD, 2005).
Nurses should observe and record the following:
Airway;
Respiratory rate (regular and effortless), rhythm and depth (chest movements symmetrical);
Respiratory depression: indicated by hypoventilation or bradypnoea, and whether opiate-induced or due to anaesthetic gases.
Oxygen therapy Oxygen is administered to enable the anaesthetic gases to be transported out of the body, and is prescribed when patients have an epidural, patient-controlled analgesia or morphine infusion. Nurses should ensure and record the following:
Oxygen therapy is prescribed;
Oxygen is administered at correct rate;
Continuous oxygen therapy is humidified to prevent mucous membranes from drying out;
The skin above the ears is protected from elastic on the mask.
Pulse oximetry Oxygen saturation should be above 95% on air, unless the patient has lung disease, and maintained above 95% if oxygen therapy is prescribed to prevent hypoxia or hypoxaemia. An abnormal recording may be due to shivering, peripheral vasoconstriction or dried blood on the finger.
Nurses should ensure that:
The finger probe is clean;
The position of the probe is changed regularly to prevent fingers becoming sore.
Heart rate, blood pressure and capillary refill time The following should be checked and recorded:
Rate, rhythm and volume of pulse;
Blood pressure;
Capillary refill time to assess circulatory status, along with the colour and temperature of limbs, also identifying reduced peripheral perfusion.
Particular attention should be paid to the systolic blood pressure as a lowered systolic reading and tachycardia may indicate haemorrhage and/or shock, although initially the blood pressure may not drop and will remain within normal limits as the body compensates. Tachycardia may also indicate that the patient is in pain, has a fluid overload or is anxious. Hypertension can be due to the anaesthetic or inadequate pain control.
Body temperature Children, older adults and patients who have been in theatre for a long period are at risk of hypothermia. Shivering can be due to anaesthesia or a high temperature indicative of an infection, while a drop in temperature might indicate a bacterial infection or sepsis.
Patients' temperature should be monitored closely and action taken to return it to within normal parameters.
Use a Bair Hugger (forced-air blanket) and blankets to warm the patient if their temperature is too low;
Choose an appropriate method to cool the patient if their temperature is too high (antipyretics/fanning/ tepid sponging).
Level of consciousness .
Postoperative patients should respond to verbal stimulation, be able to answer questions and be aware of their surroundings before being transferred to the ward and throughout the postoperative period.
A change in the level of consciousness can be a sign that the patient is in shock. The AVPU scale (Box 2) is appropriate for assessing consciousness in adults, children and young people unless they have had neurosurgery (RCN, 2011).
Fluid balance The NCEPOD (2011) found, in 30% of patient data reviewed, there was insufficient recording of postoperative fluid balance. Nurses should observe/undertake and record on the fluid balance chart the following:
IV fluids (colloids and crystalloids used to replace fluid loss postoperatively) and infusions;
Oral intake;
Urine output: catheter urine measurements should not be less than 0.5ml/kg/hour. Oliguria can be a sign of hypovolaemia and should be reported to medical staff immediately. Check that the catheter is not kinked or that the patient is not lying on the tubing if urine output is reduced;
Colour of stoma (where appropriate) and whether there is any bleeding;
Nausea and vomiting: if necessary, administration of antiemetics should be checked and vomit bowls and tissues should be within easy reach of the patient;
Oral care;
Nasogastric tube drainage (aspirate if patient feels nauseous unless otherwise indicated);
Colour and amount of wound drainage: large amounts of fresh blood could be an indication of haemorrhage; if there is no wound drainage, it is advisable to check that the drain has not fallen out.
Intravenous infusions The RCN (2010) and Health Protection Scotland (2012) recommend that peripheral venous catheters (PVC) are checked daily as a minimum, and consideration given to removing any PVC that has been in situ longer than 72 hours (Health Protection Scotland, 2012) or 72-96 hours (Department of Health, 2011).
A phlebitis scale can be used to help assess the PVC site; the Visual Infusion Phlebitis Scale (Jackson, 1998) is frequently used and recommended by the RCN (2010). These national guidelines should be used as resources in caring for PVCs. The following should be checked and recorded:
The PVC site when changing IV fluids, before administering IV medication;
Signs of phlebitis (redness, heat and swelling).
Conclusion The postoperative healthcare team is under constant pressure to discharge patients quickly. This can lead to vital signs being missed and result in a delay in recovery.
Patients can be discharged quickly only when they do not experience any post-operative complications, many of which can be avoided or identified with correct and thorough monitoring of signs and symptoms.
All health professionals must continually update their theoretical knowledge and clinical skills; those working in post-operative care can do this by relying less on electronic equipment and developing their ability to combine the use of assessment tools with good observational skills; feeling, listening for abnormal sounds and closely observing their patients.
There are guidelines issued by World Health Organisation for Post Operative Care - these are Postoperative care Post operative note and orders The patient should be discharged to the ward with comprehensive orders for the following:
• Vital signs • Pain control • Rate and type of intravenous fluid • Urine and gastrointestinal fluid output • Other medications • Laboratory investigations The patient's progress should be monitored and should include at least:
• A comment on medical and nursing observations • A specific comment on the wound or operation site • Any complications • Any changes made in treatment Aftercare: Prevention of complications • Encourage early mobilization:
o Deep breathing and coughing o Active daily exercise o Joint range of motion o Muscular strengthening o Make walking aids such as canes, crutches and walkers available and provide instructions for their use • Ensure adequate nutrition • Prevent skin breakdown and pressure sores:
o Turn the patient frequently o Keep urine and faeces off skin • Provide adequate pain control Discharge note On discharging the patient from the ward, record in the notes:
• Diagnosis on admission and discharge • Summary of course in hospital • Instructions about further management, including drugs prescribed.
Ensure that a copy of this information is given to the patient, together with details of any follow-up appointment .
(WHO/EHT/CPR: WHO Surgical Care at the District Hospital 2003 Postoperative Management) If the patient is restless, something is wrong.
Look out for the following in recovery:
• Airway obstruction • Hypoxia • Haemorrhage: internal or external • Hypotension and/or hypertension • Postoperative pain • Shivering, hypothermia • Vomiting, aspiration • Falling on the floor • Residual narcosis The recovering patient is fit for the ward when:
• Awake, opens eyes • Extubated • Blood pressure and pulse are satisfactory • Can lift head on command • Not hypoxic • Breathing quietly and comfortably • Appropriate analgesia has been prescribed and is safely established (WHO/EHT/CPR: WHO Surgical Care at the District Hospital 2003 ) Post operative pain relief • Pain is often the patient's presenting symptom. It can provide useful clinical information and it is your responsibility to use this information to help the patient and alleviate suffering.
• Manage pain wherever you see patients (emergency, operating room and on the ward) and anticipate their needs for pain management after surgery and discharge.
• Do not unnecessarily delay the treatment of pain; for example, do not transport a patient without analgesia simply so that the next practitioner can appreciate how much pain the person is experiencing.
Pain management is our job.
Pain Management and Techniques • Effective analgesia is an essential part of postoperative management.
• Important injectable drugs for pain are the opiate analgesics. Nonsteroidal antiinflammatory drugs (NSAIDs), such as diclofenac (1 mg/kg) and ibuprofen can also be given orally and rectally, as can paracetamol (15 mg/kg).
• There are three situations where an opiate might be given: o Preoperatively o Intraoperatively o Postoperatively • Opiate premedication is rarely indicated, although an injured patient in pain may have been given an opiate before coming to the operating room.
• Opiates given pre- or intraoperatively have important effects in the postoperative period since there may be delayed recovery and respiratory depression, even necessitating mechanical ventilation.
• Short acting opiate fentanyl is used intra-operatively to avoid this prolonged effect.
• Naloxone antagonizes (reverses) all opiates, but its effect quickly wears off.
• Commonly available inexpensive opiates are pethidine and morphine.
• Morphine has about ten times the potency and a longer duration of action than pethidine.
(continued next page) WHO/EHT/CPR: WHO Surgical Care at the District Hospital 2003) Post operative pain relief (continued) • Ideal way to give analgesia postoperatively is to:
o Give a small intravenous bolus of about a quarter or a third of the maximum dose (e.g. 25 mg pethidine or 2.5 mg morphine for an average adult) o Wait for 5-10 minutes to observe the effect: the desired effect is analgesia, but retained consciousness o Estimate the correct total dose (e.g. 75 mg pethidine or 7.5 mg morphine) and give the balance intramuscularly.
o With this method, the patient receives analgesia quickly and the correct dose is given • If opiate analgesia is needed on the ward, it is most usual to give an intramuscular regimen:
¾ Morphine: - Age 1 year to adult: 0.1-0.2 mg/kg - Age 3 months to 1 year: 0.05-0.1 mg/kg ¾ Pethidine: give 7-10 times the above doses if using pethidine • Opiate analgesics should be given cautiously if the age is less than 1 year. They are not recommended for babies aged less than 3 months unless very close monitoring in a neonatal intensive care unit is available.
Therefore it is clear that post-operative care is most important in a case of Surgery. If you have no infra or paraphernalia, you are not supposed to proceed further regarding operation. In this case when you go to peruse the total cases history of the patient, it was crystal clear that the opposite parties failed to provide the required post-operative care and also preoperative and operative care. When you that the patient had a known case of angina since long and the level of creatinine is more than the normal,angiography should be avoided at that stage and other treatment should be given to the patient to normalise the level of creatinine. When angiography was done, it directly affected the kidney because the ionic /non ionic contrast used was much more than the required limit which further adversely affected the kidney. It shows carelessness right from the admission till the said demise of the patient. No doubt that the doctor performed his duty with utmost care and caution but they also showed negligence in some areas . The circumstances shows that after operation, the opposite parties could not manage the complications of the patient which related in his death. It shows that the opposite parties have no proper and required paraphernalia for the operation and postoperation care. This itself shows the carelessness of the opposite party and also establishes the negligence played in this case with the complainant.
In the present case there are so many deficiencies and negligence shown by the opposite parties from the very beginning in the treatment of the patient. As discussed earlier giving of contrast dye for angiography, taking consent in a haphazard manner, not giving the treatment documents to the patient at the time of discharge/death. These are the circumstances which speak themselves and all the facts indicate towards the negligence of the opposite parties.
We have seen the haemoglobin level. As per pathological report, is on record, the haemoglobin was 5.0 on 07.09.98 AT 3.1 5 PM filed it is 6.9 at 5 AM on the same day. On 08.09.98 , the haemoglobin is 11.3. It is hard to understand that the haemoglobin level increased from 6.9 to 11.3 in one day. It can typically take between 4-6 weeks to raise ones hemoglobin levels, once ones start taking the supplements. one can also supplement his diet with foods that are rich in iron such as spinach, lentils, broccoli, dark chocolate and protein. But such increase in haemoglobin level in one day is daily surprising because thereafter on the same day and the report shows haemoglobin at 9.5 and on the very next day that is on 09.09.98 , the level of haemoglobin shown as 10.5 and 9.7. It has not been explained by the opposite parties as to how this increase and decrease in the whole available in a day happens.
From the perusal of the documents we have seen the letter sent by the registrar's, to SGPGI for sending the daily bed ticket of the patient to the concerned court. The reply sent by the SGPGI has stated on 10 November 2015 that the registration number of the patient has not been sent so it is not possible to make available the medical documents/records of the patient. When SGPGI has his advocate in this case they can very well asked him to disclose the registration number after perusing the record. Thereafter on 13 November 2015 , the registrar informed registration number of the patient to SGPGI . There is a reply of SGPGI dated 19 December 2015 informing the court that due to fire occurred on 4 November 2015, in the medical record of the cardiology department, all the records from the year 1988 to 2008 have been burnt in which the record of the Dr Bisht is also included.
It is surprising again that once you did not handover the medical records and BHT of the patient to him at the time of his discharge/death and later on he stated that the records have been burnt. No enquiry report or FIR has been filed to show that such fire occurred on the said date. No inventory has been filed to show that the burnt records include the record of the Dr. Bisht.
So after considering all the facts and discussions and also going through the various medical articles it is clear that there is negligence on the part of the opposite parties in the treatment of Dr Bisht . There is clear defficiencies in service on the part of the opposite parties. Opposite party no.2 did his best but from all the surrounding circumstances it is clear that negligence has been shown, may be not by him but by his team members and resident doctors who were on duty. In this case the consent letter is not in accordance with the guidelines. No satisfactory explanation has been given regarding removal of the pacemaker from the body of a heart patient. The dose of contrast dye given to the patient was towards higher side.
These are the circumstances which establishes the negligence on the part of the opposite parties. Opposite party no.2 is the employee of opposite party no.1 who is master of the opposite party no 2 .So in this case is opposite party no.1 is liable for the negligence and deficiency of service. The complainant has prayed a compensation of ₹ 19 lakhs which is proper in the present circumstances of the case but also as demanding of exemplary damages from the opposite party no 2 is not maintainable. Regarding cause of the complaint and any other order keeping in mind the facts and circumstances of the case, we are of the opinion to grant relief of ₹ 20 lakhs towards mental agony, mental torture, depression including cost the suit to the complainant. So the plane complainant is decided accordingly.
ORDER The opposite party no.1 is directed to pay ₹ 19 lakhs as damages/compensation for the negligence and deficiency of service to the complainant with interest at a rate of 10% from 25.09.98 till the date of payment, within 30 days from the date of judgement of this complaint case otherwise the rate of interest shall be 15% from 25.09 98 till the date of payment.
The opposite party no.1 is directed to pay ₹ 20 lakhs to the complainant towards mental agony/torture and depression with interest at a rate of 10% from 25.09 98 till the date of payment, within 30 days from the date of judgment of this complaint case otherwise the rate of interest shall be 15% from 25.09 98 till the date of payment.
If it is not paid 30 days from the date of judgment of this complaint case, the complainant shall be entitled to present execution proceedings before this court at the cost of the opposite party no.1.
The stenographer is requested to upload this order on the Website of this Commission today itself.
Certified copy of this judgment be provided to the parties as per rules.
(Vikas Saxena) (Sushil Kumar) (Rajendra Singh) Member Member PresidingMember Judgment dated/typed signed by us and pronounced in the open court. Consign to the Record Room. (Vikas Saxena) (Sushil Kumar) (Rajendra Singh) Member Member Presiding Member Dated : August 22, 2022 Jafri, PA II C-2 (सुरक्षित) परिवाद संख्या-121/2000 कुं0 पुष्पिला बिष्ट बनाम एस0जी0पी0जी0आई व अन्य माननीय सदस्य , श्री सुशील कुमार द्वारा दिया गया भिन्न निष्कर्ष 22.08.2022 :-
1. प्रस्तुत परिवाद में पीठ के अन्य दो सदस्य, माननीय श्री राजेन्द्र सिंह एवं माननीय श्री विकास सक्सेना द्वारा परिवादिनी के पिता को इलाज के दौरान विपक्षीगण के स्तर से बरती गई लापरवाही के निष्कर्ष एवं परिवादिनी के पक्ष में जारी प्रतिकर के आदेश से मैं (सुशील कुमार) सहमत नहीं हूँ।
2. परिवाद पत्र में क्रमांक संख्या-4 में दिए गए विवरण के अनुसार यह तथ्य स्वंय परिवादिनी को स्वीकार है कि मृतक वर्ष 1986 से ही Coronary Artery Disease से ग्रसित थे। विपक्षी संख्या-2, जो शिक्षित, योग्य एवं कुशल डा0 हैं, के द्वारा यह निर्णय लिया गया कि मरीज की Angiography की जाए ताकी Cardiac Treatment किया जा सके। विपक्षीगण का कथन है कि यदि यह निर्णय नहीं लिया जाता तब चूंकि मरीज किसी भी इलाज को Response नहीं कर रहे थे तब स्वंय Cardiac Dose के कारण उनका जीवन खतरे में हो सकता था। विपक्षीगण की ओर से सशपथ कथन किया गया है कि मौके पर उपलब्ध डा0 द्वारा मरीज की पूर्ण स्टडी की गई थी तथा Pathological Report की स्टडी की गई थी और यह निर्णय लिया गया था कि गंभीर Cardiac की बीमारी के कारण शीघ्र Angiography किया जाना आवश्यक है। परिवाद पत्र में लापरवाही के बिन्दु पर केवल यह आरोप लगाया गया है कि Angiography करने से पूर्व मरीज की पूर्व की बीमारियों के संबंध में विस्तृत अध्ययन नहीं किया गया, जबकि डा0 द्वारा अपने शपथ पत्र में स्पष्ट किया गया है कि Angiography करने से पूर्व मरीज की समस्त पूर्व की बीमारियों का अध्ययन किया गया था। शपथ पत्र में यह भी उल्लेख किया गया है कि मरीज के व्यक्तित्व तथा सामाजिक हैसियत को दृष्टिगत रखते हुए भी मरीज को असाधारण देखभाल विपक्षी संख्या-1 तथा संबंधित डा0 के पैनल तथा सहयोगियों द्वारा उपलब्ध कराई गई थी।
3. विपक्षीगण की ओर से प्रस्तुत शपथ पत्र में यह उल्लेख किया गया है कि Angiography करने वाले डा0 को यह पूर्ण ज्ञान था कि मरीज Renal Impairment से ग्रसित है, इसलिए समस्त सावधानियां बरती गई। विपक्षीगण की ओर से प्रस्तुत शपथ पत्र में स्पष्ट कथन किया गया है कि Angiography करने से पूर्व Nephrologist को बुलाना या उनकी सलाह लेना इलाज के लिए कदाचित जरूरी नहीं था। परिवादिनी की ओर से भी इस तथ्य को विशेषज्ञ साक्ष्य के द्वारा साबित नहीं किया गया है कि Angiography करने से पूर्व Nephrologist के द्वारा मरीज को देखना और अपनी राय व्यक्त करना आवश्यक था।
4. विपक्षीगण की ओर से प्रस्तुत शपथ पत्र में स्पष्ट कथन किया गया है कि मरीज को कभी भी Extra Dose नहीं दी गई। परिवादिनी की ओर से इस तथ्य को भी विशेषज्ञ साक्ष्य प्रस्तुत करके साबित नहीं किया गया है कि डा0 द्वारा मरीज को Extra Dose दी गई।
5. इस अवसर पर यह उल्लेख करना भी समीचीन होगा कि परिवाद पत्र के कई प्रस्तरों में डा0 के स्तर से कारित लापरवाही के बिन्दुओं का कोई वर्णन नहीं किया गया, अपितु केवल मरीज की सामाजिक हैसियत का वर्णन किया गया है। किसी मीरज की सामाजिक हैसियत के अनुसार मेडिकल ट्रीटमेंट का कोई नया आधार या तरीका इजात नहीं किया जा सकता। यही कारण है कि डा0 ए0के0 भट्ट, मेडिकल सुप्रीटेंडेंट एसजीपीजीआई ने अपने शपथ पत्र में कथन किया है कि प्रत्येक मरीज को बेहतर इलाज प्रदान किया जाता है। डा0 भट्ट द्वारा शपथ पत्र में कथन किया गया है कि मरीज वर्ष 1986 से ही Artery Disease तथा Diabetes Mellitus से ग्रसित थे, उन्हें अनेकों बार Angiography कराने की सलाह दी गई थी, जिस समय उनकी सामान्य शारीरिक दशा बेहतर थी, परन्तु उनके द्वारा बीमारी की गंभीर स्थिति पर पहुँचने पर दिनांक 02.09.1998 को रिपोर्ट की गई, जिस समय उन्हें खतरनाक छाती का दर्द था Angina Unstable था तथा LVF यानी Left Ventricular Function मौजूद था और डा0 पी0के0 गोयल द्वारा Cardiac Treatment के लिए Angiography किया गया, इस Treatment को किसी भी स्तर से लापरवाही पूर्ण Treatment नहीं कहा जा सकता। इस आयोग के समक्ष परिवादिनी की ओर से ऐसा कोई मेडिकल साहित्य प्रस्तुत नहीं किया गया है, जिससे ये जाहिर होता हो कि मरीज को अनुचित मेडिकल Treatment दिया गया। इस आयोग की पीठ द्वारा जिसमें मैं स्वंय तथा श्री विकास सक्सेना सदस्य थे, दिनांक 12.03.2021 को एक मेडिकल बोर्ड का गठन कर विशेषज्ञ रिपोर्ट प्राप्त करने का आदेश पारित किया गया था, इस मेडिकल बोर्ड में Cardiologist एवं Nephrologist को शामिल करने का भी अनुरोध किया गया था। दिनांक 22.03.2021 को केजीएमयू के मुख्य चिकित्सा अधीक्षक द्वारा सूचित किया गया कि इस चिकित्सालय में कोई Nephrologist उपलब्ध नहीं है। इस पत्र के प्राप्त होने के पश्चात पत्र संख्या-R.M.L./M.B./13/2022 दिनांकित 04.05.2022 की रिपोर्ट प्रस्तुत की गई, जो पत्रावली पर मौजूद है, इस रिपोर्ट के अनुसार इलाज के दौरान किसी प्रकार की लापरवाही नहीं बरती गई। यह रिपोर्ट 06 विशेषज्ञ डाक्टरों द्वारा तैयार की गई है, इस रिपोर्ट के विपरीत निष्कर्ष देने का कोई आधार नहीं है। अत: परिवादिनी यह तथ्य साबित करने में विफल रही है कि इलाज के दौरान किसी प्रकार की लापरवाही बरती गई। परिवाद तदनुसार खारिज होने योग्य है।
आदेश
6. प्रस्तुत परिवाद खारिज किया जाता है।
परिवाद व्यय उभय पक्ष अपना-अपना व्यय वहन करेंगे।
आशुलिपिक से अपेक्षा की जाती है कि वह इस आदेश को आयोग की वेबसाइट पर नियमानुसार यथाशीघ्र अपलोड कर दे।
(सुशील कुमार) सदस्य लक्ष्मन, आशु0, कोर्ट-2 [HON'BLE MR. Rajendra Singh] PRESIDING MEMBER [HON'BLE MR. SUSHIL KUMAR] JUDICIAL MEMBER [HON'BLE MR. Vikas Saxena] JUDICIAL MEMBER