This is a complaint filed under Section 12 of Consumer Protection Act for an order directing the opposite parties to pay an amount of              ` 2,00,000 as compensation.

          The facts of the case of the complainant in a nutshell are as follows

:  Complainant sustained a fracture on 29.01.2003 on his right femur shaft due to RTA and was taken to Indira Gandhi Hospital 3^rd opposite party had diagnosed the fracture of femur shaft and advised for operation.  Operation was conducted on 30.01.2003.  After 6 months bone grafting was also done from this hospital and started full weight bearing, as he has almost attained normality.   But complainant felt severe pain at the fracture site and again approached 3^rd opposite party.  After taking X-ray he diagnosed re-fracture at the same site.  Complainant was referred to Amrutha Institute, Ernakulam for exchange nailing with larger size nail. Complainant underwent operation at Amrutha Hospital and thereby advised bed rest and other restrictions as already undergone.   The implant used for the operation from the Hospital of 1^st and 2^nd opposite party was far below the standard and quality and hence the same was bent and cracked which resulted in fracture second time.  The implant in question was the one stocked in the pharmacy attached to the hospital run by 1^st and 2^nd opposite party.  The inferior quality of the implant caused the entire miseries including loss of employment opportunity and financial loss suffered by the complainant.  Hence this complaint.

Pursuant to the notice opposite parties made appearance and filed version.   In brief, the fact set out in version filed by opposite parties NO.1 to 3 are as follows :  Complainant was admitted to 1^st opposite party hospital on 29.01.2003 following an accident.  3^rd opposite party advised an X-ray which showed a fracture of the right femur.  A limited open reduction and internal fixation was done using 30mm X 11mm interlocking femoral nail with one proximal and two distal locking series.  Post operative period was uneventful and discharged him on 08.02.2003.  On 16.04.05 complainant reported to 3^rd opposite party with pain. X-ray revealed an angulation at fracture site with a bend a possibly cracked interlocking mail.  He was admitted and advised to undergo exchange nailing.  Since he preferred a higher centre he was referred to Amrutha on 18.04.2005. The averment that the implant was far below in standard and quality which resulted in the bending and cracking of the implant ending in second fracture in false and baseless.  Implants used were standard implants manufactured by a reputed company Pitkar Surgicals, Pune and supplied by Esquire Surgicals, Ernakulam.  The averment that opposite parties are stocking substandard implants for more profit is false.  They had brought the implants from reputed firm and are in no way responsible for the mishap.  There is no negligence on the part of opposite parties.

The brief facts of the version filed by the 4^th opposite party is as follows :  Complainant is not a consumer.  There was no brevity of contract.  The complaint is barred by limitation.  The orthopaedic implants are manufactured by this opposite party by using stainless steel material conforming to A1S1 316 specifications, manufactured by reputed steel plants.  Quality control test are also carried out at all stages of manufacturing process.  This opposite party earned a good reputation in market for this product because of the systematic and meticulous procedure employed in the manufacture of the products.  The products of the company are considered bench mark of quality.  This opposite party has been engaged in the manufacturing of the product for the last more than 48 years.  This opposite party manufacture and sells various implants of about 3,03,344 pieces per year.  This opposite party company has been certified for quality management system like ISO-9001 & ISO 13485 from DNV, Norway.  Complainant did not inform this opposite party about the failure of the implant.  The implant fixed by 3^rd  opposite party was inside the complainant’s body for more than 2 years without any trouble.  This opposite party is not aware that the alleged implant fixed at the fracture site was manufactured and supplied by this opposite party.  The bent and crack allegedly noticed by 3^rd opposite party in the X-ray of the right thigh was caused solely due to the complainant’s failure to follow the instructions given by opposite party No.3 and on failure to follow up check ups.  There was no defect in the implant and it was neither bent nor broken.  The averment that the implant used for the operations from the hospital 1^st and 2^nd opposite party was far below in standard and quality and hence the same was bent and cracked which resulted in the second fracture is false.  Complainant is not entitled for any compensation.  There is no deficiency in service on the part of this opposite party. Hence to dismiss the complaint.

          5^th opposite party filed version separately the content of which in brief are as follows:  The implant fixed by 3^rd opposite party was inside the complainant’s body for more than 2 years without any trouble.  The bent and crack noticed by 3^rd opposite party in the x-ray of the right thigh was caused solely due to the complainant’s failure to follow the instructions given by 3^rd opposite party and on his failure to follow the instructions given by 3^rd opposite party and on his failure to follow up check up. There was no defect in the implant and it was neither bent nor broken.  Non-compliance of the instructions of the Orthopaedic Surgeon and lack of post-operative care on the side of the complainant is the cause of implant failure.  The implants are intended as aids to normal healing but are not intended to replace normal body structures or bear the weight of the body in the presence of incomplete bone healing and the alleged damage or loss suffered by the complainant is only due to the non-compliance of the post-operative care and instructions of Surgeon and not due to any defect in the quality of the implant.  The complainant’s claim has no basis.  He is not entitled for any compensation.  The implant failure may happen due to improper size and its improper fixing.  There is no deficiency in service on his part.  Hence to dismiss the complaint.

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

1.     Whether there is any deficiency on the part of opposite party?

2.     Whether the complainant is entitled for the remedy as prayed in the complaint?

3.     Relief and cost?

The evidence consists of the oral evidence of PW1 and Exts. A1 to A9, Ext.B1 to B3.

Issues No.1 to 3 :

          Admittedly complainant was admitted to 1^st opposite party hospital on 21.09.2003.  3^rd opposite party doctor diagnosed the fracture of femur shaft and operation was conducted.  Bone grafting was also done after 6 months.  Since complainant felt pain at the fracture site in April, 2005 he approached 3^rd opposite party and x-ray revealed bend crack on the implant and advised him to undergo exchange nailing.  The case of the complainant is that 3^rd opposite party referred him to Amrutha Institute for exchange nailing.  Opposite party on the other hand contended that since the complainant desired he was referred to Amrutha.  Anyhow  operation was held therein.  The main complaint of the complainant is that the implant used for the operations from the hospital of 1^st and 2^nd opposite party had been far below the required standard and quality that caused the entire misery that happened to be suffered by him.

          The Power of Attorney holder, the father of the complainant adduced evidence by way of affidavit evidence in tune with the pleadings.  The main point that has to be looked into is whether the implant inserted had been substandard less with low quality.  This is a point that can only be proved by the opinion of an expert.  Complainant produced Ext.A1 to A9 documents.  None of these documents are capable of proving the quality of the implant.  PW1 in cross examination deposed that “lc-Pn-¡m-c³ D]-tbm-Kn¨ rod tamiambXpsIm­mWv s]m«n-b-Xv.  AXp KpW-\n-e-hmcw Ipd-ª-XmWv D]-tbm-Kn-¨-Xv. Opposite party No.1\pw opposite party No.2\pw em`w In«p-hm³ th­n KpW-\n-e-hmcw Ipdª rod D]-tbm-Kn¨p F¶mWv ]d-ª-Xv.”  At the same time he has also deposed that “3^rd opposite party  fix sN¿p-t¼mÄ implant\p XI-cm-dn-Ã. Bend & cracked rod implant sN¿nà F¶mWv Fsâ hni-zm-kw.  FÃv apgp-h-\mbpw  joint sNbvXm am{Xta AXn\v full weight sImSp-¡m-\mhq F¶-dn-bmw.  ]qÀ®-ambpw joinsN¿p-¶-Xn\p aps¼ full weight sImSp-¯m s]m«m³ km[-yX D­v.” It is pertinent to note that the complaint arosed only after 6 months.  Evidently after 6 months grafting was done and started walking full weight bearing.  Complainant himself admitted that he was almost attained noramality.  Hence it is very clear that the entire affairs upto 6 months had been remained well without mistake.  That position makes it clear that the operation performed by 3^rd opposite party was without mistake, which makes sure that it is not the defect of operation but something else that caused the trouble.  That may be due to  the mistake of implant. Evidently further treatment was done in Amrutha Institute.  The operating doctor in Amrutha Institute is the best person, who can more authoritatively speak of the position as an expert.  But opposite party has not taken steps for his attendance.  Complainant is also not able to get a laboratory test report of the implant.  Either the evidence of the operating doctor from the Amrutha Institute of Medical Services and Research Institute of Ernakulam or the laboratory report of the implant, alleged to be defective, is quite essential without which a correct conclusion with respect to the qualitative performance of the implant earlier used has not been possible.  Ext. B1 certificate No.2004-OSL-MDD-0240 certifies that the quality system of the product group Orthopaediac Appliances and implants manufactured by S.H. Pitkar Orthotools Pvt. Ltd. complies with the applicable requirements of the Director.  It reveals the quality system for these products has been assured according to the procedure of conformity assessment.  The devices that covered by the certificate are as follows :

-         Ring Fixation System – Big and Paedicatric.

-         Dynamic External & Rail fixation system.

-         Screws

-         Plates

-         Intermedullary locking nails.

Ext.B2 certify that the Management system of S.H. Pitkar Orthotools Pvt. Ltd. has been found to confirm to the Quality Management System Standards :  ISO 9001 : 2000 & ISO 13485 :2003.  It is seen valid for the following product or service ranges :

-         Design, Development

-         Manufacture & Marketing of Arthopaedic Implants

-         Appliances, Instruments.

Ext.B3 is the guide for retrieval and analysis of metallic orthopaedic implants.

          In the light of the absence of expert evidence the above sited documents cannot be thrown out simply since it create a silent impression that the probable conclusion with respect to the standard and quality of alleged implant can only be arrived at with the support of cogent and clear evidence.  We have gone through the entire evidence on record but failed to ascertain the standard and quality of the implant with the available materials.

          It is pertinent to note that the service of doctor, 3^rd opposite party in conducting the operation has not been challenged.  Complainant has no grievances with the procedure of operation done by the 3^rd opposite party, doctor. So the central point that has to be proved is the quality of implant without which deficiency of service on the part opposite party cannot be established.  Standard and quality of implant can only be proved on the basis of the opinion of an expert.  Hence this is an appropriate matter in which an expert opinion is required to reach a final conclusion to ascertain the standard and quality of the alleged implant.  Complainant even failed to examine the operating doctor of complainant in Amrutha Hospital who is capable of throwing considerable light on the subject matter in drawing a conclusion.  So also it would have been more helpful if the complainant himself come forward to give evidence by way of affidavit in respect of the facts which are in exclusive knowledge of the complainant.  It can be seen many of the material facts given in affidavit evidence are in exclusive knowledge of the complainant.  Absence of independent corroborative evidence weakened the case of the complainant to make fast liability to make fast liability and deficiency in service upon opposite parties.  The power of attorney failed to depose very material facts before the Forum. PW1 failed to answer what was the nature of the work the complainant was doing between 19.04.2003 to 19.04.2005.  Opposite parties have a case that during these period anything could have been happened like over strain on the operated leg against medical advice, a fall etc.  If complainant was in the box he could have very well answer these questions in the cross examination. It is pertinent to note what PW1 depose in cross examination in this respect that “ 19.04.2003 apX 19.04.2005 hsc lcPn¡mc³ ho«n rest-embncp¶p.  Cu Imebfhn Fs´ms¡bmWv sNbvXncp¶Xv F¶v F\n¡v IrXyambn ]dbm³ IgnbnÃ.  Discharge sN¿pt¼mÄ PW3 Fs´ms¡ sN¿Wsa¶v lcPn¡mc t\mSmWv ]dªXv”  So also he answered to another question “cretches D]tbmKn¡Ww F¶p ]dªp.  {I¨knsâ klmbanÃmsX lcPn¡mc³ \St¶m F¶p F\n¡p ]dbm³ IgnbnÃ.” The absence of answers in material points will badly affect the case of the complainant.  This is a case wherein, the test result of implant has not been available, whatever may be the reason for taking or not taking effective steps.  Thus the available evidence is not sufficient enough establish the case of the complainant.

          In the light of the above discussion we are of opinion that the deficiency in service on the part of opposite parties has not been proved with cogent and clear evidence and thus we are unable to grant any relief to complainant.

          In the result, the complaint is dismissed.

          No order as to costs.

          Dated this the 14^th day of  August, 2012.

                    Sd/-                         Sd/-                        Sd/-                 

       President                  Member                   Member

APPENDIX

Exhibits for the Complainant

A1.  Power of Attorney.

A2.  Bills(15 in number)

A3.  Lawyer notice

A4.  Postal receipt.

A5.  Acknowledgement card.

A6.  Certificate issued by State Board of Technical Education.

A7.  Reference letter by 3^rd opposite party.

A8.  Discharge summary from AIMS dated 25.10.07.

A9.  Discharge summary from AIMS dated 26.04.05.

Exhibits for the opposite party

B1. Copy of Certificate of Assessment.

B2. Copy of Management System Certificate.

B3. Copy of guide for retrieval and analysis of metallic orthopaedic

       implants.

Witness examined for the complainant

PW1.  C.H. Raveendran

Witness examined for the opposite party

Nil                                           

Forwarded by order

                                                               SENIOR SUPERINTENDENT