V MOHAN RAO vs MIOT HOSPITALS

-THIS appeal is filed against the order of the State Consumer Disputes Redressal Commission, Tamil Nadu at Chennai passed on 30. 11. 2004 in the Original Complaint No. 269 of 1998 whereby the complainant V. Mohan Rao''s complaint alleging deficiency in service and medical negligence by the opposite party No. 1, Miot Hospital and No. 2, Dr. P. V. Mohan Das, has been dismissed. Brief facts of the case are: appellant''s submissions:

THE appellant (the original complainant) Mr. V. Mohan Rao, a Civil Engineer, is presently residing in Bangalore. On 19. 7. 1997, when he was in Chennai, he slipped in the bathroom and developed severe pain. Respondent No. 2, Dr. P. V. Mohan Das, diagnosed that it is advanced Avascular Necrosis (AVN) of the right femoral hip with Osteoporosis. He was advised to undergo total hip replacement by way of surgery since the femur was damaged and need to be replaced with steel one. AVN, in ordinary language, means death of the femoral head due to snapping of supply of blood as the complainant was diabetic and there was also thinning of bones. It can be caused due to either primary or idiopathic (sudden development without any traceable causes ). The hip is the largest weight bearing joint in the body and it consists of two main parts-a ball (femoral head) at the top of the thighbone (femur) that fits into a rounded socket (acetabulam) in the pelvis. As a result of the death of the femoral head due to AVN, the head of the femur has to be replaced by a metal prosthesis which in turn is cemented. The Orthopedic Surgeon has to choose the type of prosthesis. It is the case of the appellant that the 2nd respondent performed an advanced surgical procedure called hybrid hip replacement operation. Total Hip Replacement (THR) if done properly is known to give complete success and the average incidence of dislocation after total hip anthroplasty is approximately only 3%.

The surgery was conducted by the 2nd respondent on the appellant on 17. 11. 1997 and he was discharged on 28. 11. 1997. But the appellant continued to have pain although Dr. Mohan Das assured him that the operation was successful. The X-ray, which was taken on 30. 12. 1997 in the Apollo Hospital, showed that the trochanter bone with the stem had torn at three places and it had moved up. Dr. Mohan Das advised him to take further complete rest and opined that there was still possibility of union with the growth of fibrous tissue. The appellant went to a place called Rajula to take rest.

THE appellant consulted different doctors and showed the X-ray taken on 30. 12. 1997 and they opined as under, that: (i) the cup was fixed vertically, (ii) the wires were broken, trocanter bone moved up, (iii) Screws of the cup are longer than the required length.

Dr. Mohan Das then suggested trochanteric attachment to the appellant. It is contended that- (a) the appellant is regularly suffering from bouts of numbness on entire right side of his body, (b) if the broken/snapped wires touch the sciatic nerve, the appellant would be affected by nerve palsy, (c) the respondent has put abnormally long screws which are abutting the bladder by which the bladder is exposed to risk of rupture. Appellant therefore has to go to urination at frequent intervals to ensure an empty bladder to avoid risk.

Learned Counsel for the appellant contended that negligence of the 2nd respondent would be established by considering the treatment given during three different stages, i. e. : 1. Pre-operative; 2. During the operation procedure, and 3. Post-operative treatment. (a) Pre-operative-Necessary tests were not carried out as per the standard medical practice, i. e. to do a CT scan and Roentgenograms of the pelvis to see whether the bone is sufficient for the fixation of the acetabular component and to evaluate the acetabular so that it would have been easy for the respondent No. 2 to perform the operation on the operating table. Pre-operating templating of roentgenograms is helpful in determining the size and placement of the socket within the available bone stock. The appellant further submitted that the respondents cannot, at this stage, contend that they have taken X-rays, as this plea was never taken before the State Commission nor did O. P. No. 2 stated so in his deposition and it is clear that the respondents are trying to improve the case now. Although the respondent No. 2 averred that decision was taken up on the operation table to do the vertical positioning of the acetabulam cup which was necessitated due to the alleged softness of the sub-chondreal bone, this could have been avoided had he carried out the evaluation by reviewing roentgenograms of the pelvis to see whether the bone is sufficient for fixation of the acetabular component. Appellant made specific reference to medical literature (Campbell''s Orthopedics -page 374 ).

(b) Templates/models not prepared- It is further argued that the respondent''s contention that the question that there was not enough purchase (enough bone stock) ought not to have arisen at all since the bone stock, softness/quality of bone are all determinable before the surgery by X-rays, roentgenograms and templating. The appellant consulted the respondent No. 2 on 12. 11. 1997 and the surgery was conducted on 17. 11. 1997 which gave sufficient time for pre-operative test to determine the adequacy to fit, the presence of circumferential bone contact, and the adequacy of the bone coverage of the component; using the trial components also allows the surgeon to make a mental note of the positioning of the component before final implantation.

(c) Selection of screws-The longest screws which had been fixed in the prohibited area (quadrant) were abutting the bladder and carried a risk of rupturing the bladder. He relied on the subsequent X-rays, which have been placed on record.

(d) During the procedure-The appellant averred that respondent No. 2 has been negligent in performing the surgery contrary to standards as given below:

(a) Vertical positioning of the acetabular cup- (i) It is submitted that optimal inclination of the socket is 45 degrees and this is supported by Campbell''s Operative Orthopedics (pages 353-355) whereas the respondent No. 2 have given total vertical positioning and justified it that this was necessitated due to quality of the bone and further in the cross-examination (page 86 of Vol. 1) deposed that, "even if 10 doctors say like that, I do not agree with them". Had the respondent No. 2 assessed the quality of the bone by way of templates and roentgenograms, as explained earlier, doctor would have been in a position to assess the situation correctly before the surgery itself.

(ii) The contention that the softness of the chondreal bone necessitated the vertical placement was not sustainable since the acetabulam is a weight bearing bone which undergoes reaming, grinding and drilling for placement of screws and hence, the contention of the respondent No. 2 is not sustainable as the acetabulam cannot be soft since it has to take 12 times of body weight even after operation. Malpositioning of the screws/length of screws: respondent No. 2 has placed longer screws, which carry risk of jutting into and injuring the bladder, and further he has placed these anterosuperior screws that too in the area of prohibited quadrant. The diagram in Campell''s Operative Orthopedics (page 354-355 Volume VII) shows that anterosuperior quadrant should be clearly avoided and the respondent No. 2 has not considered this risk by positioning the long screws which are clearly seen in the scan report taken at Manipal Hospital. Post-operative:

(a) Trocanteric non-union-vertical positioning of the cup-On 30. 12. 1997 the appellant had taken an X-ray which shows that there is trocantric non-union but the respondent in his report dated 30. 12. 1997 noted that the components are in excellent position. In view of the negligence of the respondent No. 2, it is submitted that the condition of the appellant kept deteriorating so much so that on 11. 2. 1998 even Dr. Prabodh Desai clearly mentioned that there was trocantric non-union wires being broken or vertical positioning of greater trocanter. Accordingly, he advised re-surgery and the X-rays which had been taken between 30. 12. 1997 and 11. 2. 1998 demonstrate that it has deteriorated consistently. Snapped wires-Campbell''s Operative Orthopedics-10th Edition-page 415 says : "trochanteric wires are identified as source of pain because of Bursa formation over broken twisted wires. Removal of wires occasional indication. But Bernard and Brookes found that fewer than 50% of patients obtained substantial relief from wire removal, occasional broken wires migrate into joints or towards sciatic nerves producing delayed nerve palsy. There are also chances of getting the patient paralyed for life. The fragmentation of newly braided cable may generate a large amount of intra articular metal debris that damages the articulative surfaces. Complete excision of this type of wire debris at revision is almost impossible and subsequent revision may be at risk for accelerated wear". It is submitted that there are all chances of appellant getting paralysed. It is argued quoting Campbell''s page 455 Vol. VII, that-"this frictional torque is transmitting to the cup, the stem of the femoral component, the surrounding cement, and the cement bone interface as a force that tends to fix the components. It may move the stem and crack the cement or move the mass of cement. Any movement of the cement or increase in shear force at the cement-bones interface causes bone absorption". Therefore, an increase in frictional torque force may result in loosening of the femoral component which has happened to the petitioner.

(b) No proper attention/followup.

IT is contended that the respondent No. 2 after reviewing the appellant on 6. 2. 1997 did not advise any caution or notice any abnormality. The contention of the respondent doctor is that the appellant did not follow the advice given as per the discharge summary. As against this, the appellant averred that he followed all the instructions and yet there was no relief, as it was due to the negligence of the doctor while performing the surgery. The appellant is suffering immensely as a consequence of the negligence of the 2nd respondent and the affidavit filed by the Government Hospital estimated his disability at 55% which is not disputed by the respondents. Learned Counsel for the appellant submitted that respondent No. 2 Doctor has not exercised reasonable and competent degree of skill as is expected of a professional thereby rendering negligent/deficient service entitling the appellant to compensation.

THE State Commission held that appellant''s condition perhaps got aggravated by regular consumption of alcohol which was not supported by any record or evidence.

THE claim of the complainant for Rs. 19,50,000 has been dismissed by the State Commission on the following grounds: (a) that longer screws have not damaged the bladder till now and since no harm has been done all these years it cannot be considered to be deficiency in service by the doctor; (b) that since bone was soft and there was no sufficient purchase to help the lining fixed to the acetabulam the doctor had to go in for longer screws to give better stability; (c) that snapping of wires and moving of trochanter bone cannot be in any manner held to be a direct consequence of any act of the doctor, respondent No. 2; and (d) lastly, since there is no expert opinion forthcoming from the complainant side it was held that there was no deficiency or negligence on the part of the doctor. Submission of the respondent Nos. 1 and 2:

Respondent No. 2 deposed in his affidavit that he had done 5500 to 6000 total hip replacement surgeries in a period of 30 years. The appellant when contracted him complained of pain in the right hip for 18 months; that he had difficulty in walking; that pain followed after a slip in the bathroom one-and-a-half years before his examination; that he found stiffness of the right hip and could not move; that there was shortening of the right leg by one and a half inches; that the diagnosis revealed advanced AVN in the right side with Osteoporosis and that the left hip similarly was also showing early changes.

It is submitted that considering the quality of the bone and its condition, he had to choose the best mode of fixing the cup and the screws so that there will be stability and maximum movement of the joint without causing dislocation of the components, which is a decision which has to be taken by the surgeon on the operation table. It is further stated that the operation and post-operative period was uneventful and the complainant was discharged at his request since he wanted to go away on personal ground. Even after operation he was frequently coming for check-up and met him on 6. 12. 1997 and there was nothing wrong with him. The appellant was also able to walk very well. The X-ray taken on 30. 12. 1997 at Apollo Hospital shows that the wires were intact and the components were in excellent position as they were in place. Two sets of wires were used - one wire seems to have snapped. It is submitted that the snapping of a wire is an accepted complication in this procedure as world average itself is 18%. As long as the components are in position the snapping of the wire is of no consequence.

THE appellant telephoned from Rajula in February stating that the wires were snapped and that he was suffering from severe pain. Dr. Mohan Das suggested him to come to Chennai for examination in February 1998. X-rays were taken and components were found intact and the respondent doctor suggested the appellant only trochanteric reattachment. But the appellant got himself operated by Dr. Bhatt. According to the operation notes of Dr. Bhatt, the hip joint of the appellant was stable in all positions. Hence, the surgery done by Dr. Mohan Das is correct. Even the re-surgery is required not due to negligence on the part of the Surgeon. A successful surgery depends on the age, eating habits, health condition, etc. In his cross-examination, when the question was put as to whether the longer screws could puncture the bladder if appellant had sustained sudden fall or when bladder is full, Dr. Mohan Das stated that "since there was not enough purchase available I had to use longer screws to obtain better stability of the cup. Further the serial X-rays have not been taken and therefore all the dimensions have not been brought out. " It is submitted that the appellant underwent further operation on 1. 4. 1998 at Amar Hospital. After the re-surgery also Dr. Bhatt did not reduce the length of the screws while performing the surgery for trochanter. In the discharge summary it is stated "hip joint was stable. The acetabulam was stable in all directions".

EVEN during this operation, Dr. Bhatt did not shift the vertical fixing of the cup to an angular fixing as he had taken into account the factual condition of the patient. If the contention of the appellant has to be believed that the vertical fixing constitutes deficiency then it was open to Dr. Bhatt to fix the same to ensure better mobility of joint. The very fact that Dr. Bhatt did not do anything regarding angular fixing and reducing the length of screws shows that the first surgery was done taking into consideration the condition of the patient. It is submitted that in order to help the muscles and the ligaments to heal and get formed, these are held by wires. The wires by themselves do not have any significant part except in the first three weeks. They are primarily used to ensure stability until the cut muscles and ligaments during operation recoup and held the ball and socket. It is stated in his evidence that "the snapping of the wire is an accepted complication and the average in the world is 18%. One should not rush into surgery but must wait. As long as the components are in position the snapping of the wire is of no consequence".

REGARDING the length of the screws, since Dr. Bhatt has not reduced the length of the screws while performing the surgery for re-attaching the trochanter and the fact that the screws have not damaged any other organ and it is still holding the wires or its snapping, hence, it cannot be said that there is deficiency and negligence on the part of the respondent No. 2.

IT is reiterated that Dr. Bhatt who conducted the re-surgery/revisional operation has also made no attempt to remove the so-called long screws obviously because he found that the operation procedure carried out by the present respondent is correct. Further they referred to the operative notes of Dr. Bhatt which states "there was trochanter bursa with broken K-wires, bursa cleared and all K-wires removed". If the broken wires were removed then how they could be seen in the recent X-ray. Further, it is contended that there is only one reported case of palsy in all over the world even though almost one lakh hip operations are carried out every year for the last 30 years. It is averred that although in total hip replacement the ideal way of fixing the cup is at 45 degrees but it is always not possible as it depends on the patient''s condition. In the present case the quality of the bone of the acetabulam was poor and the cup could not be fixed at an angle of 45 degrees. Respondent No. 2 in his evidence relying on the operative notes states that "considering the quality of the bone and its conditions I have to choose the best mode of fixing the cup and the screws so that there will be stability and maximum movement of the joint without causing dislocation of the components, which was decision taken by the Surgeon at the operation table. I do not agree with the statement of the complainant that the cup should not have been fixed vertically and should have been fixed angularly. "

Regarding pre-operative procedure, the C. T. scan only indicates whether there is any structural defect in the acetabulam as in the case of fracture dislocation of the hip but it cannot give any indication regarding bone quality. It is stated that C. T. scan can suggest only for patients with developmental dysplasia or with old fracture dislocation and not otherwise. C. T. scan can be used to evaluate the acetabulam and would not give any indication of the bone condition. Hence, it is submitted that there is no deficiency in service on the part of the respondent No. 2.

IT is further submitted that hip joint is dynamic in nature and absorbs lot of pressure at different positions of the body like sitting, standing, bending, squatting, etc. , the exertion of the pressure on a hip joint has a direct impact on the holding of the wire or its snapping. As long as the components are in position the snapping of wires is of no significance. The pre-operative treatment accorded was in accordance with the established canon of medical profession. So far as the operation and post-operative care is concerned, respondent No. 2 submitted that he has used the highest possible skill and care. There are always several modes of treatment for any particular problem and adopting one of them by the operating surgeon, in preference to the other in the best interest of the patient after assessing the condition of the patient does not amount to negligence or deficiency in service. In the present case, the respondent No. 2 adopted the right mode of treatment after seeing the real internal condition of the patient on the operation table and hence, it cannot be constituted negligence on the part of respondent No. 2. Further, it is contended that the appellant was not staying in Chennai and there is no record to show as to how well he had adhered to the instructions given for post-operative period. In the absence of any information, it is incorrect to foist negligence on the part of the doctor. The pre-operative treatment was accorded to the patient in consonance with the established canon of medical profession. The operation and the post-operative care were uneventful. There was no complication while performing the operation or thereafter. It is submitted that the respondent No. 2, doctor had explained everything to the appellant regarding the bone that it was soft and there was no purchase available and hence he had to use the longer screws to ensure better stability. It is also averred that even though a decade has gone past the length of the screws or the vertical fixing has not caused any damage to any organ or the hip. Hence, there is no negligence on the part of the doctor.

FURTHER, the appellant being diabetic, smoker and occasional drinker, respondent No. 2 has to take these factors into consideration while performing the surgery. These factors contribute to the healing process negatively and also the collagen in diabetic patient is less. In addition to the above, if the appellant increases the pressure on the hip joint by any additional activities, there can be a stress on the said joint. It is submitted that respondent No. 2 has acted in accordance with the established principles of medical profession and appellant has not proved anything by examining any other doctor that the procedure adopted is incorrect. There is no expert evidence brought on record by the appellant to prove negligence. He relied on the Campbell''s 10th Edition page 354 Part III Arthroplasty wherein it is stated: "if a system using an offset polyethylene liner is being used, the metal shell can be implanted in a slightly greater degree of abduction so that the porous surface makes better contact with the underlying bone, and the offset of the polyethylene liner is used to place the final abduction angle of the assemble component within the acceptable range".

IT is pointed out that Dr. Mohan Das, respondent No. 2 has performed 10,000 hip replacement surgeries till date. He has been trained in Joint Replacement Surgery in England and has pioneered total hip replacement in India. Findings:

WE have heard both the parties and perused the medical records, affidavits and cross-examinations. The issues that need to be decided for finding out whether there is any medical negligence, are as follows: (i) Whether placing the longer screws by the respondent No. 2 protruding into pelvis is a negligence because it could puncture urinary bladder due to proximity; (ii) Whether the wires which were snapped and remained in the body is considered to be negligence; (iii) Whether the placement of the screws vertically instead of placing them in an angle of 45 degrees has been instrumental in the trochanter displacement; (iv) If any of the above three issues are decided in favour of the appellant, then what will be the amount of compensation that is required to be awarded. It is an admitted fact that the appellant was suffering from Avascular Necrosis of the right hip and was required total hip replacement, which is not contested. As for the pre-operative treatment or post-operative care is concerned, it was accorded to him in consonance with the established medical norms and there was no complication while performing the operation or thereafter.

The respondent doctor in his affidavit and cross-examination has admitted the usage of longer screws. He has stated that this was necessitated because there was not enough purchase available so he used longer screws to obtain better stability of the cup. Surgery was performed ten years back and till date screws have not damaged any of the organs and hence fixing the longer screws cannot be said to be deficiency in service.

THE respondent doctor submitted that he chose the best mode of fixing the cup and the screws and placed in the poster-superior quadrant correctly in order to avoid any injury for that he relied on the reference of Campbell''s 10th Edition, page 354, Part III Arthroplasty which is given as under: "however, the drill bit and screw threads can be palpated in the vicinity of the sciatic notch as they emerge so that injury of these structures can be avoided. The postersuperior quadrant is the safest, and screws in excess of 25 mm frequently can be placed through strong bone in this area. The anterosuperior quadrant should clearly be avoided if possible. "

Respondent Doctor in his deposition stated: ". . . . considering the quality of the bone and its condition I have to choose the best mode of fixing the cup and screws, so that there will be stability and maximum movement of the joint without causing dislocation of component. This is the decision taken by the Surgeon at the operation table. There are no fixed rule or standardized procedure. . . . . . . . . . . . . . . . . . "

We do not find any deficiency in service by the respondent doctor in fixing the screws in the quadrant, which gave enough stability to the cup and also in view of the purchase available at the time of surgery.

HE further submitted in his written arguments that, "at his last post-operative check up on 30. 12. 1997 the components were in position and the complainant was walking well. Thereafter, when the second opposite party saw the complainant 1 months later the trochanter required re-attachment but the hip joint itself was stable which is the most crucial part of the TRH. The fact that the complainant required re-surgery is not evidence of any negligence on the part of the second opposite party. . . . . . . that success of any orthopaedic surgery depends upon the patient''s general health, age, eating habits, quality of the bone, etc. In the complainant case he is a diabetic and obviously suffering from progressive degenerative disease of the bone as evidenced (emphasis ours) by the fact that when he was admitted in the first opposite party in November 1997, the doctors found that left hip also showed early signs of avascular necrosis. The complainant seems to have had THR of his left hip also in the year 1999. The complainant''s condition may perhaps have been aggravated by the regular consumption of alcohol. " We agree with the above submission of the respondents. Since the appellant was already suffering from progressive degenerative disease of the bone which also has its own effect in the process of recuperation. Further, even Dr. Bhatt, who conducted the re-surgery recorded that hip bone was stable and the acetabulam was stable in all directions. Dr. Bhatt also demonstrated and shown the stability to patient''s attendant, who is also a doctor and mentioned this fact in his operative note. It is submitted that if the screws were not placed in such a position both the hip joints and acetabulam would have become unstable. It is very important that the screws need to be positioned without damaging the arteries, vein and nerve. Dr. Bhatt did not make any attempt to remove the alleged longer screws and hence there is no likelihood of damage to the bladder as alleged by the appellant.

AS for the second issue regarding snapping of the wires is concerned, we accept the submission of the respondent that this is an accepted complication of this operation and the world average is known to be 18%. The appellant''s contention that broken trochanteric wires could migrate into the joint or towards sciatic nerve, producing delayed nerve palsy, we find these K-wires were not removed although Dr. Bhatt stated in his operative notes that he had removed the K-wires. After the second post-operative surgery these K-wires are shown in the X-ray which means that these were still present. The appellant''s submission that he has filed another case against Dr. Bhatt and Amar Hospital for not removing these K- wires is not part of this case.

THE respondent''s submission that there is only one reported case of palsy in all over the world even though almost one lakh hip operations are carried out every year for the last 30 years, is rational. Hence, in our view, no deficiency can be attributed to the respondent on account of snapping of wires. Learned Counsel for the respondent submitted that during the post-operative period appellant was staying in another place called Rajula (in Gujarat ). There is no record to show how he adhered to the instructions and hence we do not find any evidence as to what has happened during his stay in Rajula during which time snapping of wires occurred. Claim of negligence on this account is not sustained.

Thirdly, as for the argument that placement of cup vertically instead of placing them in an angle of 45 degrees has been instrumental in trochantric displacement, the respondent strongly denied this. He relied on the Campbell''s 10 Edition, page 354, Part 3 Arthroplasty "if a system using an offset polyethylene liner is being used, the metal shell can be implanted in a slightly greater degree of abduction so that the porous surface makes better contact with the underlying bone, and the offset of the polyethylene liner is used to place the final abduction angle of the assemble component within the acceptable range".

FOURTHLY, Dr. Bhatt did not shift the vertical fixing of the cup to an angular fixing as he had also taken into account the factual condition of the patient. It is submitted by the learned Counsel for the respondent No. 2 that it is the Surgeon''s decision either to fix the cup at 45 degrees angel or totally above (vertical) to ensure greater mobility of the joint. This decision cannot be questioned considering the fact that Dr. Bhatt too had not shifted vertical fixing of the cup to an angular fixing, as contended by the appellant. Hence, we see no merit in the contention of the complainant and reject the same As regards the allegation of the appellant that C. T. scan would have been taken pre-operatively to evaluate the acetabulam, the contention of the respondent is that in pre-operative stage C. T. scan could not give information regarding bone quality. Further, the C. T. scan is suggested only in the patients of dysplasia or in the old age people with fracture dislocations and not otherwise. Hence, we are of the opinion that the allegation of the complainant is baseless and we also find no deficiency in service on the part of the respondent that he did not assess the bone quality during the surgery.

ALTHOUGH Dr. Bhatt noted on 12. 4. 1998 before the second surgery that screws of the metal back were projecting excessively into the pelvic cavity and that the acetabular cup was vertically aligned, he has not done anything in the second surgery except attaching the trochantric back. In view of the aforesaid discussion on the three issues to be decided, we find no negligence or deficiency in service by the respondents and agree with the findings of the State Commission. There is no reason for us to interfere under our revisional jurisdiction with the well reasoned order of the State Commission. The Appeal stands dismissed accordingly. There shall be no order as to costs. Appeal dismissed.