National Consumer Disputes Redressal
Mr. Alfred Benedict & Anr. vs M/S Manipal Hospital Bangalore & Ors. on 22 May, 2013
NATIONAL CONSUMER DISPUTES REDRESSAL COMMISSION
NATIONAL CONSUMER DISPUTES REDRESSAL
COMMISSION
NEW DELHI
FIRST APPEAL No 275
of 2007
(Against the order dated 5/4/2007 in Complaint
No.55/2004;Karnataka State Consumer Disputes Redressal Commission,Bangalore)
1. M/s Manipal Hospital Bangalore,
(A Unit of Medical Relief Society of South
Kanara, (Regd.),
No. 98, Rustom Bagh, Airport Road,
Rep. by R. Basil, Chief Executive Officer
Bangalore-56043
i) Medical Relief Society of South Kanara,
Manipal EDU,
University Building,
Manipal -576104
2. Dr. Meera Ramakrishnan,
Pediatrician, Pediatric Intensive Care
Unit.
3. Dr. Vasudeva Rao,
Vascular Surgeon,
4.
Dr. Arvind Shenoy,
Consultant Pediatric
5. Dr. Jayanth Iyengar,
Pediatric
Surgeon
Petitioners
Versus.
1. Mr.
Alfred Benedict,
2. Mrs.
Rani Benedict
Both
residing at
No.
18, Trinity Blossom
Geddalahalli,
Hennur
main Road,
Bangalore-56043 .Respondents
FIRST APPEAL No 178
of 2008
(Against the order dated 5/4/2007 in Complaint
No.55/2004;Karnataka State Consumer Disputes Redressal Commission,Bangalore)
1. Mr.
Alfred Benedict,
S/o Mr. Edwin Tobbias
No.18, Trinity Blossom
Geddalahalli,
Hennur Main Road,
Bangalore-43
2. Mrs.
Rani Benedict,
Parents of Sandria Rinu Benedict(Baby Sandria)
No.18, Trinity Blossom
Geddalahalli,
Hennur Main Road,
Bangalore-43 .. Petitioners
Versus
1. M/s Manipal Hospital Bangalore,
(A Unit of Medical
Relief Society of South Kanara, (Regd.),
No. 98, Rustom Bagh,
Airport Road,
Rep.
by R. Basil, Chief Executive Officer
Bangalore-56043
ii) Medical Relief Society of South Kanara,
Manipal EDU,
University Building,
Manipal -576104
2. Dr. Meera Ramakrishnan,
Pediatrician, Pediatric Intensive Care
Unit.
3. Dr. Vasudeva Rao,
Vascular Surgeon,
4.
Dr. Arvind Shenoy,
Consultant Pediatric
5. Dr. Jayanth Iyengar,
Pediatric Surgeon .Respondents
BEFORE:
HONBLE MR.
JUSTICE ASHOK BHAN, PRESIDENT
HONBLE MRS. VINEETA RAI, MEMBER
HONBLE Dr. S.M. KANTIKAR, MEMBER
For Appellant : Mr.
Vivek Singh, Adv.
For Respondent
1 & 2 : Mr. Joshna Samuel Adv.
Pronounced
on ..May 2013
ORDER
PER DR. S.M. KANTIKAR
1. Two cross-appeals are filed, namely, First Appeals No. 275 of 2007 and F.A.178 of 2008, have been filed by M/s Manipal Hospital Bangalore and Mr. Alfred Benedict and Anr. Opposite Party and Complainant respectively before the Karnataka State Consumer Redressal Commission, Bangalore (hereinafter referred to as the State Commission) challenging the order dated 05.04.2007 of that Commission. Since the facts and the parties in both first appeals are common/similar arising out of the same consumer dispute, it is proposed to dispose of these appeals by one common order by taking the facts from First Appeal No. 275 of 2007. The parties will be referred to in the manner in which they were referred to in the complaint i.e. Mr. Alfred Benedict and Anr. will be referred to as Complainant and the M/s Manipal Hospital Bangalore and ors as Opposite Party.
2. Complainants took their two-year-old daughter who was suffering from cold and cough to opposite party No. 4-doctor who advised them to admit her in opposite party No.1-hospital. On admission she was taken to pediatric intensive care unit and diagnosed that she was suffering from cold & cough as well as from pneumonia. She was given intravenous fluids by inserting needle on the dorsal aspect of right wrist from Aug. 26, 2002 to Aug. 28, 2002: however, the baby developed gangrene initially in the finger tips which spread to the portion of the hand below wrist joint due to blockage of blood supply. The complainants further contend that on 29.08.2002 and 30.08.2002, OPs 2 to 4 conducted Angiogram and confirmed that there was complete blockage of blood supply to the right forearm. The Opposite parties conducted operation on the right forearm to restore blood supply but the same could not be restored and, eventually, the daughter of the complainant had to lose her right forearm. It is alleged that the complainants, thereafter, came to know that the needle was wrongly inserted into artery instead of vein due to which the blood supply was blocked. Thus, imputing the opposite parties of negligence and deficiency in service, complaint was filed before the State Commission praying compensation of Rs. 1,00,00,000/- as the complainants daughter has to spend the rest of her life without the right forearm.
2. OPs contended that the gangrene of right forearm was due to septic shock. They contend that what happened to the patient in this case was a known complication and its not a case of negligence in any treatment given in their hospital. They deny that there was any negligence on the part of the OPs. They also deny liability to pay compensation.
3. The OPs have filed common version before the State Commission contending that at the time of admission in the hospital the baby was not only suffering from cold & cough, but also suffering from pneumonia. It is further contended that the baby was having microcephaly and recurrent seizures and was being seen by Dr. S.R. Suresh Rao Aroor for seizures and developmental delay. According to the OPs,the baby was also suffering from Pharyngitis. She was found toxic coupled with fever and was having weak cry due to worsening Pharyngitis. They further contended that she was drowsy, irritable & had developed signs of Broncho pnenumonia. They have denied that the child was conscious or alert when she was admitted in the hospital; OPs have admitted that when the patient was in Pediatric Intensive Care Unit (PICU), oxygen was administered and I.V. fluids were administered with intravenous cannula. In the early morning of 27.08.2002, the patient was diagnosed to have metabolic acidosis. Blood pressure started dropping, for which, bolus of normal saline was given. At about 2.30 PM, the patient was seen by OP2 who started the patient on injection dopamine. At 3.30 PM, BP was not recordable by non-invasive means due to septic shock. Hence, right radial arterial line was started by Dr. Sandra and arterial BP monitoring started. Throughout that day, BP remained low and dopamine had to be increased. It is contended that only single use cannula was used for administration of I.V. Fluids and intra radial use.
4. OP-2 has admitted that at about 8.00 AM on 28.08.2002, the right index and little fingers of the patient were found to be cyanosed and swollen. However, they contend that it was noticed by the nursing staff and not by the Complainants. They further contended that at about 8.10 AM, Dr. Venkatesh on information saw the child followed by OP2 at 10.00 AM and cannula was removed. The patient was referred to the vascular surgeon Dr. Vasudeva Rao-OP No. 3, who examined the patient and advised elevation of the right forearm and infusion of heparin. It is contended that no surgery could be done because it was only the microvasculature that was affected. They further contend that OP3 decided to continue heparinisation and elevation of the limb. Doppler study showed presence of arterial pulsation till the level of wrist. On 29.08.2002, OP3 advised angiography and the same was done by Dr. Subhash Chandra, a consultant Invasive Cardiologist, which showed no flow beyond the brachial artery. OP No 3 contended that it was due to intense spasm of all the vessels and an aberrant right sub clavian artery; and that after injecting vasodilators (Pepaverine and Nitroprusside), some flow was seen in the radial and ulnar arteries and palmar arch and situation was duly explained to the Complainants by OP3. Fasciotomy was also done on 29.08.2002 which means opening up of the covering of the muscles of the arm in order to relieve pressure and to establish better blood supply. OPs, however, contend that there was no question of any situation for amputation. On 30.08.2002, the patient was seen by OPs 2 & OP-5 being a consultant pediatric surgeon; having gone through the records, advised to do Right Cervical Sympathetic Nerve Block was performed in consultation with Dr. Parameshwara, Consultant Anesthetist. Following this, there was improvement in the cold area of the upper arm, which became warm below the elbow. The procedure was repeated on 31.08.2002.The patient was managed conservatively till the line of demarcation became apparent. On 14.12.2002 the complainants had informed OP5 about the falling of the gangrene part. The patient was brought to OP5 who noticed that a little edge of bone was jutting out. The patient was readmitted on 16.12.2002 and dressing was done. Subsequently, the patient was regularly seen by OP5 and the wound was dressed regularly till it healed fully. The OPs contend that it was unfortunate that complications had taken place and the patient was being resuscitated for septic shock which could have been fatal.
5. The State Commission after hearing the parties and on the basis of evidence produced before it allowed the complaint by observing as follows:
I.According to the OPs, the gangrene that affected the right fore arm of the child had nothing to do with the Hospital or the Doctors or the treatment given by them and it was due to septic shock. But, OPs have made an attempt to improve their case in the affidavit filed by OP4-Dr. Aravind Shenoy, who, at para 21 of his affidavit has stated that infection which started with Pharyngitis spread to the lungs to cause pneumonia and subsequently increased so much resulting in the fall of blood pressure. When blood pressure falls, blood supply to non-vital organs other than the brain, heart & kidneys is reduced or cut off resulting in the severe reduction of blood supply to the limbs. If the reduction in the blood supply is very severe as it was in this case, as proved by Angiography, gangrene could occur in spite of all possible measures, which were very promptly taken by the concerned specialists in the Hospital. Such instances though rare are known. This case is one such typical case where despite best efforts of the Doctors, limb could not be saved.
II.
OPs have not produced expert evidence or medical literature to show that this explanation is acceptable.
The OPs, therefore, have failed to rule out the possibility of having caused cyanosis on account of cannulation or arterial invasion. This is a case where res ipsa loquitor applies. We, therefore, hold that the treatment given to the baby Sandria at OP1 hospital suffers for want of proper care and in other words, the treatment was deficient.
III. Cannulation and arterial invasion was done as per the advice of OP2. There is no clear cut evidence as to who exactly was the person who did the cannulation and arterial invasion, because that was done in the ICU and the complainants being the parents of the child were outside the ICU. However, OP1 being employer is vicariously liable for the negligence committed by the doctors and the nursing staff working in the hospital.
The complainants have claimed compensation of Rupees One Crore under various heads. According to the complainants, they and the child have suffered physically & mentally and also incurred heavy expenses for the treatment of the child. They have produced bills, which are marked as Ext. C3, which go to show that they have spent more than Rs. 1,10,000/- for the treatment of the child. They have also produced at Ext. C13, a letter from Otto Bock Health Care, which shows that more than Rs. 12.00 lakhs are required for providing artificial limb to the child who has lost the right fore arm.
6. State Commission in the order dated 5/4/2007 therefore directed the opposite party No.1 to pay Rs.500000/-to the complainants which shall be spent for the rehabilitation of baby Sandria by providing artificial limb and proper education and care. OP-1 was further directed to pay Rs.10000/- to the complainants towards the cost of litigation. Order be complied within 30 days failing which the same shall carry interest @ 10% p.a. from August 25,2004 till the date of payment.
7. Against the order of State Commission two separate appeals have been filed. Appeal FA No.275/2007 is filed by the respondents in which they have challenged the order of State Commission. The complainant filed appeal FA No 178/2008 for enhancement of compensation amount. Both the appeals are disposed of by this single order.
8. Learned Counsel for opposite party essentially reiterated the facts as stated by them in the rejoinder filed before the state commission. We have carefully gone through the evidence and records of PICU made on 26-28 August 1993, which has brought some element of suspicion in our mind about the treatment of baby Sandria.
It is not disputed that Baby Sandria was admitted in PICU under treatment of OP 2-5 for treatment of Pneumonia and who subsequently suffered septic shock. It is apparent that patient required an immediate attention and proper care. The medical record placed on file shows that patient was on IV lines, Oxygen supply and Blood pressure monitoring. Therefore, at this juncture it important to discuss;
Why gangrene had developed only in the Right hand?
Was there any negligence by the OPs in PICU?
Whether OPs failed in performing their duties as per standards of medical practice?
Could it be labeled as a medical negligence?
Point No.1:
As contented by OP-3 that during septicemia, when blood pressure falls, blood supply to non-vital organs other than the brain, heart & kidneys is reduced or cut off resulting in the severe reduction of blood supply to the limbs. For recording of Blood pressure the OP performed Rt radial artery cannulation; but they have ignored that the use of arterial catheter may contribute mechanical obstruction to the blood flow also. Therefore, only the right hand in which cannulation was performed showed gangrenous changes and other limbs did not show any signs of gangrene even-though there was of severe reduction of blood supply.
Point No.2:
The records show that the right hand was swollen; but the reason for it was not recorded in the case sheet. As per medical literature during septicemic shock; there will be severe collapse of peripheral veins and therefore it will be difficult to administer the IV fluids. The baby Sandria was in septicemic shock and was advised several IV medications. Due to collapsed veins it was difficult to locate veins despite several attempts, and such multiple pricks led to rupture of veins or small arteries of the right hand during IV medication. In such instance infusion of fluid in subcutaneous tissue instead of veins leads to swelling of hand.
Point No.3:
Radial arterial cannulation procedure itself needs expertise and it should be performed by a doctor who has expertise and experience in such procedures. As per the standards of medical practice, it the duty of a doctor to maintain all the records in detail pertaining to treatment, any procedures, interventions under his signature as to time, name of person performing the procedure, site of cannulation, technique of puncture (transfixation/direct fixation technique), method adopted, the size and type of cannula/catheter (teflon or polypropylene) etc. Though the OP 2 contended in her version that with her advise Dr.Sandra started Rt radial artery line but, we did not find any cogent evidence or any entries in the case sheet about the procedure performed by Dr.Sandra. The complainants being the parents of the child were outside the ICU. Therefore, who exactly was the person who did the radial artery cannulation in the ICU is matter of concern. Hence, we can reach the conclusion that the nursing conducted the radial arterial cannulation.
Point 4: Furthermore, OPs contended that, due to septicemia baby Sandrias Blood pressure (BP) was not recordable therefore Right Radial Arterial line was started to monitor the blood pressure (BP) of patient. Since, that Manipal Hospital is one with international standards having sophisticated ICU infrastructure etc. It is expected that , the PICU will have facilities like Multi-parameter monitors (which can record ECG, Pulse, SPO2, Invasive BP recording graphs etc). As the patient was in PICU on admission it is more surprising that OP did not produce any acceptable records like the ICU electronic BP recording graphs/ charts, Pulse oxymeter/SPO2/ABG records. We have observed the manual recordings made in continuation sheets, which are not a substitute for automatic electronically monitored records like graphs, printouts or photographs. Such manual records can be created any point of time.
Point No 5: Early recognition of gangrene is the most important means to reduce permanent injury. The patient herein was catherised in the afternoon at about 3 pm and next day morning at 8 am the hospitals staff noted the bluish discoloration of fingers i.e. after 17 hrs. Throughout night, if the PICU staff would have vigilant such delay would have been prevented. Transient blanching and cyanosis of the lower extremeties are the most common ischemic manifestations and should serve as a warning sign and an indication for catheter removal In our opinion to prove their case the Ops failed to produce several concrete records pertaining to hand Doppler study and Angiography study by the way of graphs, printouts etc. Even we did not see the detailed procedural aspects of Cervical Sympathetic Block or Fascioctomy which the respondents performed. The entries made in the progress sheet should be supported by proper records, printouts, graphs or films etc. We have relied upon several medical texts, literature and reviews:
In the article titled Radial Artery Cannulation: A Comprehensive Review of Recent Anatomic and Physiologic Investigations (Anesth An alg 2009:109:1763-81) it is clarified that the radial artery is the preferred site for arterial cannulation as it has consistent anatomic accessibility, ease of cannulation and low rate of complications. A combination of profound circulatory failure, hypotension and high dose vasopressor therapy may increase in the risk of hand ischemia , the Table No 6 of the article also highlighted the several risk factors assessment before radial artery Catheter Placement (catheterization).
Under the heading of catheter and placement technique the related risks are stated as:
Inexperienced operator Hematoma at punctured site Vasospasm of radial artery precipitated by manipulation of catheter Other factors like-
Number of puncture attempts Large indwelling catheters(> 20 guage) Polypropylene catheter (In comparison of teflon catheter) Female gender Infiltration of local anaethetic aroud radial artery precipitating vasospasm Transfixation cannulation technique(In comparision to direct puncture cannulation technique).
Recannulation of previously cannulated artery.
In another review article published in The South African Journal of Critical Care, Vol. 4, No.1,1998 titled Complications Of Arterial Lines discussed.
The various complications of arterial lines discussed in this review should be incorporated into management algorithms for critically ill patients. Complications of arterial monitoring lines are uncommon but can produce serious morbidity. Constant awareness and early recognition are the key to reducing this morbidity. Arterial cannulation for pressure monitoring and blood gas analysis is a common procedure in critically ill patients. The radial artery is the most frequently used, but other arteries are also used.
Hand Ischemia Following Radial Artery Cannulation:-
Prolonged cannulation, Catheter size and, arterial and the insertion technique have been implicated as predisposing to ischaemia. Thus, the femoral artery has been recommended for prolonged catheterization. In the shocked patient on vasoactive drugs, where radial artery catherization carries a high risk of ischaemia the femoral artery may also prove safer.
Whenever the question of ischaemia arises, prompt removal of the catheter is mandatory, as these changes are often reversible after de-cannulation.. The usual tendency is to temporize and treat the patient conservatively because spontaneous recannalization of the thrombosed artery can be expected. Proximal intra-arterial injection of papaverine or reserpine and sympathetic ganglion blocks have been tried in attempts to overcome peripheral vasoconstriction, which is, believed to contribute to ischaemic damage. Intravenous heparin and dextran have also been used. It is unclear whether these empirical measures are of any benefit.
In a Case report cited in S.Afr Med J 1985;68;491-492 titled as Gangrene of the hand and forearm after inadvertent intra-arterial injection of pyrazole : explains about ;
The inadvertent intra-arterial injection of solutions meant for intravenous use results in arterial injury, a situation which is being recognized with increasing frequency. In recent years, many reports describing one or several cases of intra-arterial injection of various drugs have underlined the disastrous effects. Prevention of intra-arterial injections is of paramount importance.
9. The OPs did not substantiate their ground to prove their contention that there was no negligence because it appears they have not followed the standards of medical practice when conducting the arterial cannulation on the patient.
10. The principles of what constitutes medical negligence is now well established by number of judgments of this commission as also the Honble Supreme Court of India, including Jacob Mathew vs. State of Punjab [(2005) 6 SSC 1] and in Indian Medical Association Vs V.P.Shantha [(1995) 6SSC 651]. One of the principles is that a medical practioner is expected to bring a reasonable degree of skill and knowledge and must also exercise a reasonable degree of care and caution in treating a patient (emphasis provided). In the instant case, it is very clear from the facts stated in forgoing paragraphs that a reasonable degree of care was not taken in treatment of patient in PICU.
11. Medical records revealed that patient was on higher antibiotics and several IV medications. We have referred to medical literature, which clearly state that inadvertent intra-arterial injection in the radial artery was the main cause of gangrene of the hand or fingers. It is also to be noted that the Right little finger also showed signs of gangrene. Thus, there was also injury to ulnar artery.
The swelling of the right hand is due to multiple pricks for IV lines and further damaging the arterial circulation. We, therefore, hold that due care was not taken during the invasive procedure i.e. Right radial arterial cannulation to baby Sandria in PICU which ultimately resulted in gangrene. This clearly constitutes medical negligence and deficiency in service.
12. Therefore on the basis of medical texts and reviews on the arterial cannulation it is apparent, as stated earlier that not maintaining proper records of invasive procedures, charts, graphs is the deficiency in medical treatment. Apart from this the doctors from appellant hospital have not able to explain how the gangrene of Right hand occurred. Therefore the instant case is case of res ipsa loquitur where medical negligence is clearly established and for which OPs are liable. OP1 being employer is vicariously liable for the negligence committed by the doctors and the nursing staff working in the hospital.
13. In the first appeal 178/2008 the complainant prayed for enhancement of compensation. We agree that complainant suffered mental agony and spent more than Rs.1,10,000/- for the treatment of the child as bills produced. Considering the facts that the child has to spend the entire life without her right forearm, we feel that interest of justice requires that compensation of Rs. 5,00,000/-, in the least, has to be granted in favour of the complainant. We therefore, agree with the order of State Commission and up hold the same and pass the ORDER as follows:
The present both the appeals FA No.275/2007 and FA No. 178/2008 are dismissed. The Appellants are directed to pay Rs.500000/-to the complainants which shall be spent for the rehabilitation of baby Sandria by providing artificial limb and proper education and care. OP-1 was further directed to pay Rs.10000/- to the complainants towards the cost. Order be complied within 45 days failing which the same shall carry interest @ 9% p.a. from the date of this order till the date of payment.
..
(ASHOK BHAN J.) PRESIDENT ....
(VINEETA RAI) MEMBER ..
(Dr. S. M. KANTIKAR) MEMBER