DOF.9.7.2003

IN THE CONSUMER DISPUTES REDRESSAL FORUM, KANNUR

Present: Sri.K.Gopalan:  President

Smt.K.P.Prethakumari:  Member

Smt.M.D.Jessy:               Member

                                                  Dated this, the 8^th  of  June 2010

C.C.No.240/2003

K.P.Shyju,

Vrindavan,

P.O.Pattannur                                                                           Complainant

(Rep. by Adv.P.P.Jayarajan)

1. Managing Director,

   Dhanalakshmi Hospital, Kannur.

   (Rep. by Adv.P.Mahamood)

2. Dr.Y.Ramachandra, Ortho surgeon

   Dhanalakshmi Hospital, Kannur.

   (Rep. by Adv.P.Mahamood)

3. Dr.K.Narayana Prasad,

   Senior Consultant (Ortho Surgeon)

   Dhanalakshmi Hospital, Kannur.

   (Rep. by Adv.P.Mahamood)

4. Managing Director,

   M/s.Sakthi Ortho Paedic Industries Pvt.Ltd.,

   No.5 Kausalya Park Basement)

   Hauz Khas,

   Aurobindo Marg,

   New Delhi 110016.                                                               Opposite parties

   (Rep. by Adv.T.Ravindran)

5. Proprietor,

   M/s.Esquire Surgical,

   Chelavannur Road, Cochin

   (Rep. by Adv.T.Ravindran)

O  R D E R

Sri.K.Gopalan, President

            This is a complaint filed under section 12 of consumer protection act for an order directing the opposite parties to pay a sum of Rs.2, 00,000/- as compensation together with the cost of these proceedings.

            The complainant’s case in nutshell is as follows; the complainant met with a road traffic accident on 31.1.02 and admitted to the hospital,the 1st opposite party. He was subjected to an operation of tibia and fibula of the right leg.  2^nd opposite party conducted the operation. He was discharged on 11.2.02 and paid an amount of Rs.61, 533. Few months after the discharge complainant had been experiencing pain in the operated part. He was again admitted on21.12.02. He was examined by 3^rd opposite party and detected that the nail implanted was broken. So broken nail was replaced by new one after a major operation.  1^st opposite party collected Rs.27, 249/- towards hospital charge. The implanted original nail was broken since it was qualitatively inferior. The bones were not united due to the failure of the implant. Complainant could not even stand erect for few months and unable attend his employment for more than 6 months. Complainant sent a legal notice calling upon to compensate by paying an amount of Rs.2, 00,000/-. Opposite parties 1 and 2 sent reply denying the liability. As per their reply opposite parties 4 and 5 the manufacturer and seller also arrayed as opposite parties. It was alleged that the cause of implant failure was due to the type of initial injury. It was not correct. Opposite parties 1 to 3 failed to confirm the quality of implant before it was implanted. The opposite parties are jointly and severally liable to compensate the complainant.

            Pursuant to the notice the opposite parties entered appearance and filed version denying the main allegations of complainant.

            The case in brief of the 1^st opposite party is as follows: the complainant was admitted in the hospital on 31.1.02. Resident Orthopedic surgeon Dr.Y.Ramachandra initially examined him. He diagnosed as type III B compound fracture of right tibia and fibula with fracture femur on the same side. All necessary investigations including X-ray and blood investigations were done. After doing initial resuscitation he was referred to the 3^rd opposite party Dr.Narayana Prasad, the consultant in orthopedic Department of Hospital. Three major surgeries were done in single stage. The whole procedure was done by Dr. Narayana Prasad assisted by the second opposite party Dr.Ramachandra. The post operative period was satisfactory and the patient was discharged on 11.2.02 with advise of non-weight bearing, crutch walking. Later when he was on regular follow up as out patient serial radiological and clinical evaluation was carried out. On 19.9.02 he was referred to Dr.Anand Joshi, who is well known Arthroscopic surgeon to evaluate the patient’s posterior crucial insufficiency. Thereafter the patient did not report for follow up.; later on21.12.02 the complainant reported to this hospital with pain and swelling of his right leg. Fresh X-ray revealed tibia nail at fracture site and the proximal locking bolt was broken. He was admitted on the same day and was operated on 24.12.02 removing the broken implant and doing necessary procedures. After discharge he was on regular follow up till 7.4.03 and the fracture was consolidating by that time. The cause for the hardship to the patient was not due to any faulty treatment or substandard implant but it was the result of the initial injury, committed and compound fracture life threatening injury resulted from road traffic accident. There is no deficiency of service on the side of his opposite party. Hence to dismiss the complaint.

            2^nd opposite party filed version denying the main allegations of complainant as follows. The complainant brought to hospital 1^st opposite party on 31.1.02 with alleged history of Road Traffic accident. He is Resident Orthopedic surgeon of 1^st opposite party. He had seen the patient shyju initially and examined diagnosed to have type III B compound committed fracture of right tibia and fibula with fracture femur on the same side. X-rays and blood investigations were done. After doing the initial resuscitation this opposite party had informed the 3^rd opposite party Dr.Narayana Prasad who is the consultant surgeon in the orthopedic department of 1^st opposite party.  Patient was admitted on31.1.02 and taken up for surgery. The surgical procedure were done by 1^st opposite party Dr. Mahayana Prasad and 2^nd opposite party had only assisted him. The procedures done were wound debridement zero hour closed reamed inter locking, nailing of the femoral fracture, undreamed closed interlocked nailing of the tibia fracture and primary split thickness skin graft to cover the skin defects. Patient was discharged on 11.2.02 with advice of non weight bearing and crutch walking. 2^nd opposite party agreed with all contentions raised by 1t opposite party and repeated the same. He has repeated the same contentions as that of 1^st opposite party and stated that he has not given any treatment to the complainant.

            3^rd opposite party filed version agreeing with opposite parties 1 and 2 and repeated almost all the same contentions. He has stated hat Dr.Ramachandra diagnosed to have type III B compound comminuted fracture of right tibia and fibula with fracture femur on the right side. The whole surgical procedures were done by him with the assistance of 2^nd opposite party. The post operative period was uneventful. He was discharged on 11.2.02 with advice of non-weight bearing crutch walking. Thereafter the patient was on regular follow-up as on outpatient where several radiological and clinical evaluations was carried out. On 19.9.09 he was referred to Dr.Anand Joshi to evaluate his posterior cruciate insufficiency. Thereafter the patient did not report for follow up. On21.12.02 he came with pain and swelling. Fresh X-ray revealed the tibia nail at fracture site and the proximal locking bolt was broken. Operation was conducted on 24.12.02. The procedure done was removal of the broken implants and revision; interlocking nailing with IIX 330 mm, center pulse (Salzer) nail with a dynamic proximal locking slot and cortical cancelions bone grafting was done from the left iliac crest. The patient was on regular follow-up till 7.4.03 and the fracture was consolidating by the time. The nail implanted during the course of the surgery was not broken at that time and the check X-ray taken following surgery proves the same. For several months the complainant had no problems and nail was detected to have broken when he approached on 21.12.02. All efforts were taken to restore functions to the complainant after the injury and the treatment given was according to the most scientific medical norms. Implant failure is a probable complication resulting from the compound communited fracture. The complainant had not continued follow up with this opposite party for a long time as advised. The complainant had reported back only on 21.12.02 with pain and swelling and breakage of the implant. The complainant was not available for follow up or advice for three months from 19.9.02 till21.12.02.So the entire incident do not involve any deficiency of service or negligence on the part of this opposite party as alleged by the complainant. Compound (type III) communited fracture of the tibia with ipsilateral fracture femur with lejamentous injuries of the same is a very serious and life threatening injury. The compound  comminuted nature of his fracture as well as lack of proper of the injured leg during the period when the complainant was lost for follow up,  have contributed to the failure of the implant. Nail implanted were standard quality. The hardship and loss of earning suffered was due to the severe RTA injuries sustained by the complainant and was not due to the treatment given to the complainant by the opposite party. There is no negligence or deficiency of service on the part of opposite party hence to dismiss the complaint.

            4^th opposite party filed versions contending as follows: This opposite party is an ISO 9001 certified company founded in the year 1989 and has since been developing and manufacturing implants and instruments for fracture treatment and joint replacements. The implants manufactured by 3rd opposite party are especially subjected to strict quality control measures. The  raw material used for manufacturing the implants meets all the requirements of international standards like ISO, DIN and ASTM etc. quality control measures are carried out at all points during manufacturing process and before dispatch of the product in to the market for sale. The opposite party has been engaged in the manufacturing of implants for the last 14 years and till date received any complaint. The nails manufactured and supplied by 4th opposite party to 5th opposite party do not suffer from any latent or patent infirmity. The allegation that the complainant suffered on account of the nails which were not standard quality is a baseless allegations. It is not inferior quality. There is always a risk of implant failure due to various reasons. The compliance of the instructions of the surgeon is absolutely necessary for achieving the result for using the nail and if the instruction is not adhered to the implant could bent or break while inside the body. The alleged damage or less suffered by the complaint is only due to the non compliance of the post operative acre and instructions of the surgeon and not due to any defect in the quality of nail there is no deficiency on the part of the opposite party and hence to dismiss the complaint.

            On the above pleadings the following issues have been taken for consideration.

1. Whether there is any deficiency in service on the part of opposite parties?

2. Whether the complainant is entitled for the remedy? If so what is the quantum?

            The evidence consists of PW1, DW1, and Exts.A1 to A7, B1 to B6, MO1 and MO2.

Issue Nos. 1 and 2

            Admittedly the complainant was admitted in the hospital, 1st opposite party due to road traffic accident. 2^nd opposite party conducted operation of tibia and fibula of his right leg. On 11.2.02 he was discharged.

            Complainant’s allegation is that few months after the discharge he had started suffering pain in the operated portion. 3^rd opposite party examined him and detected the nail implanted was broken. Complainant’s case is that the implant was broken since its quality was inferior and opposite parties 1 to 3 failed to confirm the quality of implant.

            Opposite parties 1 to 3 on the other hand contended that 2^nd opposite party initially examined him and diagnosed as type III B compound fracture of right tibia and fibula with fracture femur on the  same side. Three major surgeries were done in single stage. The whole procedure was done by Dr.Nrayana Prasad 3^rd opposite party assisted by the second opposite party. Post operative period was satisfactory and he was discharged with advice of non-weight bearing, crutch walking etc. Serial radiological and clinical evaluation was carried out. On 19.9.09 he was referred to Dr.Anand Joshi to evaluate posterior cruciate insufficiency. Thereafter patient did not report for follow up. On 22.2.02 he came with pain and swelling. X-ray revealed that the tibia nail and locking bold was broken. All the necessary procedure was done and broken implant was removed. The patient was on regular follow up till 7.4.03. Opposite party’s main contention is that the complainant had not continued follow up for a long time as advised and the implant failure is a probable complication resulting from the compound communited fracture.

            The complainant was admitted to the hospital on 31.1.02. He as discharged on 11.2.02. Mr.Shyju, the complainant has been referred to Dr.Anand Jhoshi, consultant Anthroscopic surgeon, Mumbai for expert evaluation management of the patient’s posterior cruciate insufficiency. Ext.B1 proves that he was referred on 19.9.02. The evidence goes to show that post operative period up to the reference on 19.9.02 had been without compliant and satisfactory.  Ext.B1 also reveals that the final diagnosis as “Type III B compound communated Right tibia and fibula with fracture femur”.

            Complainant was admitted in the hospital again on21.12.02 with complaint of pain. He was examined by3rd opposite party and detected that the nail implanted at fracture site and the proximal locking bolt was broken. 3^rd opposite party adduced evidence by proof affidavit that fresh X-ray revealed the tibia nail at fracture  site and the proximal locking bolt was broken. Operation was   conducted on 24.12.02. Ext.B2 reveals   the operative procedures done was removal of the broken implant and revision of inter locking nailing and bone grafting. Check list dt.24.12.02 in Ext.B 2 case sheet shows the name of surgery as removal of broken nail, re nailing and bone grafting. Operation report in Ext.B2 also confirms the operation. Surgical procedures recorded in operation report also show that removal was done and 330 x 11 mm sultzer nail was put. It also reveals that cortica cancellus bone grafting was done from the left iliac crest. Complainant has not challenged these facts.

            The evidence adduced by PW1 by way of chief affidavit states that Imen Dd-¸n¨ s\bnÂKp-W-\n-e-hm-cT Ipd-ª-Xm-b-Xn-\m-emWv BbXv s]m«n-t¸m-Im-\n-S-bm-b-Xv.         The quality of implant was not proved by a test, though complainant has the case that the implanted nail in the first operation was qualitatively inferior. It is pertinent to note that from 11.2.02, the date of discharge of complainant up to the day of reference on 19.2.02 the first nail implanted was intact. What all happened to complainant after 19.9.02 to 21.12.02 the day of reporting again to hospital has not been explained by complainant. It is clear from the evidence that there was no follow up during this period. The evidence of his father PW1 that “19.9.2002 apX 21.12.2002 hsc Bombaybn aI\v Fs´-ÃmT kT-`-h-n¨p F¶p-F-\n-¡-dn-bn-Ã. tUmIvS-dp-sS-\nÀt±-i-§Ä Cu  Ime-b-f-hn ]ment¨m F¶p F\n-¡-dn-bnÓ`reveals that PW1 himself was not sure whether the complainant had been strictly followed the advise of the doctor during this period. Activities of the complainant during this period is a determining factor without which it is difficult to draw a correct conclusion that there was no fault on the side of the complainant for causing damage to the implant inserted by the operation. If the complainant himself adduced evidence there would have been a correct picture since he was alone competent enough to say about his activities during this relevant period he had been spent in Bombay. PW1 father is not at all aware of complainant’s activities in Bombay. Hence non examination of complainant weakened the case of complainant to a great extent. It cannot be ignored the fact that the placing of implant is for the purpose of support of bone and not a replacement of bone. Hence it is highly essential to make sure that the advice of the doctor had been followed strictly especially in the light of serious nature of injury sustained by the complainant. Moreover, PW1 is not able to give any evidence on the question of pain and sufferings undergone by the complainant. PW1 cannot depose about the material facts within the exclusive knowledge of complainant as is held by Hon’ble National Commission in the reported case in II (2009) CPJ 207(NC). PW1 has deposed that discharge  sN¿p-T-t]mÄ    Shyju   hnt\mSv  weight FSp-¡cp-sX-¶pT crutch walking am{Xta ]mSp-f-fq-F-¶pa Imen\p    weight   sImSp-¡-cn-sX-¶pT aq¶mT FXnÀI£n ]d-ª-Xmbn And-bmT:. But no evidence has been brought before the Forum to show that these instructions had been followed by the complainant during the above mentioned period of his stay in Bombay. It is seen that implant was intact when he met the doctor last before leaving to Bombay. There was no complaint neither of implant nor of any treatment from 31.1.02 to19.9.02. In other words complainant was fully satisfied with the operation and treatment underwent in the hospital of 1^st opposite party. More over a prudent man cannot believe that a doctor will insert a defective implant in a human body. It is cruel if we go to that extent, even if there is degradation in almost all fields.

            It is also important to see that complainant has not taken keen interest to prove the quality of the alleged implant inserted in the first operation. It is not proved that the rode which was implanted by the opposite party was either defective or its implantation was defective. In the recent case Rupendra Kuriar Sahu vs. Dr.Akhilesh Sabu reported in I (2010) CPJ 3 State Commission held that in the absence of any medical opinion medical negligence was not found proved. More over complainant could not remove the doubts well and clear with respect to the implant. PW1 deposed in cross examination that the road implanted in the second operation was measured II X 33 cm centre pulse (Sulzer). He deposed thus: “24.12.02 operation \S-¯n. s]m«nb  nail and bolt amän-]-I-cT  11 m X 33 cm centre pulse (Sulzer)F¶ nail LSn¸n¨p  . MO1 measured 9 mm x 38 cm, whereas, MO2measured 10 mm X 38 cm. The concerned doctor 3^rd opposite party by his evidence also confirmed the size of the nail implanted in the second time was 11 mm X 33 cm. Then arose the question where does the MO2  10 mm X 38 cm come from.MO1 is measured 9 mm X 38 cm complainant could not succeeded in proving that MO2 is the nail implanted on 24.12.02 in place of the broken MO1.

            In the light of the above discussion we are of opinion that the complainant failed to establish his case. The issues 1 and 2 are found against the complainant.

            In the result, the complaint is dismissed. No cost.

Sd/- President              Sd/- Member               Sd/- Member

APPENDIX

Exhibits for the complainant

A1.Copy of admission and discharge certificate issued by OP

A2.Copy of discharge card issued by OP.

A3.Cop;y of salary certificate.

A4.Bills

A5.copy of taxi bills

A6 & 7.Copyof the lawyer notice sent to  Ops and reply notice

Exhibits for the opposite parties

B1 & 2.Admission record of complainant maintained by OP

B3 to 6. X-rays

B7.Test certificate issued by TCR Engr. services

Witness examined for the complainant

PW1.Kunhikrishnan.P.V

Witness examined for the opposite parties

DW1Dr.Narayana Prasad

Exhibits for material objects: Mos 1 & 2           

                                                            /forwarded by order/

                                                            Senior Superintendent