JASBIR KAUR vs Duchem Laboratories Limited

IT is alleged in the amended complaint that the complainant after having fallen in her house on 6.5.1997, was taken to Batra Hospital, New Delhi where she was attended by OP No. 3 -Doctor. X -ray of the complainant showed that she was having fracture in bone in her left thigh. Opposite party No. 3 suggested insertion of an Inter -locking Nail'' by way of operation. He procured Inter -locking Nail'' manufactured by Pfizer Inc. and Howmedica International Inc. through opposite party No. 2, authorized agent of OP No. 1 who was the distributor of the manufacturer in India. The number of Inter locking Nail'' was 10 -380 (H) K340690. Complainant was discharged from hospital on 11.5.1997. It was further alleged that the complainant had severe pain at the place the Inter -locking Nail was inserted. She was, therefore, taken to Lok Nayak Jaiprakash Hospital at New Delhi on 26.6.1998. Her X -ray was taken which showed that the inserted Inter -locking Nail had broken. On 13.7.1998, broken Inter -locking Nail was removed and another Inter -locking Nail manufactured by the said Company was inserted on the advice of treating Orthopaedic Surgeon. It was stated that broken Inter -locking Nail was of sub -standard quality. It had caused huge financial loss and physical torture to the complainant. OP No. 4 is a Sales Officer of OP No. 1. Complainant through Counsel sent a notice to the opposite parties. OP No. 4 was deputed by OP No. 1 to visit the place of complainant, inspect the broken Inter -locking Nail and collect X -ray, etc. Manufacturer lastly asked the complainant to supply the pre -operation and post -operation X -rays as also broken Inter -locking Nail in addition to medical reports in original complainant sent the photographs of the broken Inter -locking Nail and all other documents. Despite that the manufacturer has failed to settle the claim. Direction was sought to be given to pay compensation of Rs. 50.00 lakh with interest @ 12% p.a. to the complainant.

OPPOSITE party Nos. 1, 2 and 3 contested the complaint by filing separate written versions. Opposite party No. 4 did not file written version. It was alleged by OP No. 1 that it did not supply the Inter - locking Nail in question for consideration to the complainant and had no privity of contract with her. Inter -locking Nails are manufactured at Kiel, Germany by Howmedica International Inc. which has been deleted as a party in the amended complaint. Shanon Warehouse, Ireland is responsible for supply of the products manufactured by Howmedica International Inc. Answering opposite party is an authorized distributor of Howmedica International Inc. in India. Complainant had purchased the Inter -locking Nail from OP No. 2, dealer of the opposite party. It was stated that the products manufactured by Howmedica International Inc. meet the requirements of EN ISO 9001: 1994, EN 46001: 1996. It had been granted EC certificate No. Gl 99 0313931 017 which certifies that the products manufactured by the Company are in conformity with directive 93/42/EEC concerning medical devices. Company is also registered with Foods and Drugs Association, USA. Breaking of the Inter - locking Nail in question itself would not amount to defect therein within the meaning of Consumer Protection Act, 1986 ( for short the Act). It was further alleged that complainant had failed to disclose that Dynamisation was done by Dr. Rajiv Sharma, AIIMS. Inter -locking Nail in question would have broken due to other reasons including negligence on the part of complainant and non -union of the bone. Inter -locking Nail is merely an aid for natural fracture healing process and is meant only to maintain the anatomical position of the fractured bone. It cannot act as a substitute to the bone. Inter -locking Nail in question was of good quality as is demonstrated by the fact that it was intact for 13 months after surgery despite their being non -union of the bone. In response to the last notice dated 26.8.1998, the answering opposite party had sent letter dated 14.9.1998. By another letter dated 15.10.1998 the complainant through Counsel was informed that it was necessary for examining the claim of the complainant that Inter -locking Nail in question is sent along with X -rays and other relevant documents still the complainant failed to take the requisite steps in the matter. It was pleaded that the Inter -locking Nail in question being imported was not the goods'' within the meaning of Section 2 (1) (i) of the Act. Liability to pay the amount claimed was emphatically denied.

OPPOSITE party No. 2 in its written version alleged that it was a dealer of OP No. 1 and procured the Inter -locking Nail in question from OP No. 1. It received a small commission on sale of the implant and is not responsible as regards quality of the Inter -locking Nail in question which was supplied in packed condition. In his written version, opposite party No. 3 alleged that complainant was seen by him in Batra Hospital OPD on 6.5.1997. She was found to have fracture shaft of left femur after a fall. Complainant was advised admission and operation. Complainant underwent Inter -locking Nail of femur on 7.5.1997 and was discharged from hospital on 11.5.1997 with advice to attend OPD on 21.5.1997. Complainant failed to attend the OPD on 21.5.1997. Complainant attended the OPD on 11.7.1997. Her X -ray showed little callous. There was virtually no sign of union of bone. So, the answering opposite party advised the complainant to come back in a month''s time for repeat X -ray and if union was not found to be proceeding satisfactory the complainant was warned that she may need Dynamisation. After 11.7.1997, the complainant never visited the answering opposite party for follow -up. It was asserted that best possible medical treatment was provided to the complainant.

BY way of evidence, the complainant filed her affidavit. Affidavits of Deepak Hanumant Thite and Klaus Dieter Nothacker were filed by opposite party No. 1. Affidavit of V.L. Narayan was filed on behalf of opposite party No. 2. Opposite party No. 3 filed his affidavit of evidence. Complainant, Deepak Hanumant Thite and opposite party No. 3 - Doctor were subjected to cross -examination. Despite opportunity being given the complainant did not serve interrogatories for cross -examination of said Klaus Dieter Nothacker.

COMPLAINT against opposite party No. 3 -Doctor seems to be based on deficiency in service while against remaining opposite parties on the ground of the Inter -locking Nail in question being of sub -standard quality/ defective. To be only noted that no allegation of negligence in treatment against opposite party No. 3 has been made either in the complaint or in affidavit filed by way of evidence by the complainant nor even any suggestion for negligence in treatment has been given in cross -examination to opposite party No 3. Complaint against opposite party No. 3 has, thus, to be dismissed.

COMING to Inter -locking Nail in question being sub standard/defective, it was contended by Shri R.K. Vashisht for the complainant that it is not in dispute that the Inter -locking Nail inserted by way of operation in the left thigh of the complainant on 7.5.1997 by opposite party No. 3 had broken on 26.6.1998. This could be only due to its being of sub -standard quality/defective which fact was even admitted in the letter date4 23.2.1999 by Pfizer Inc. whereof Howmedica was a Division. Opposite party No. 1 being distributor in India of Howmedica International Inc. - manufacturer and opposite party No. 2, dealer of OP No. 1, therefore, cannot escape liability for payment of the compensation. On the other hand, it was argued by Mr. Aditya Narain for OP No. 1 that the complainant had not lead any evidence to prove that the Inter -locking Nail in question was of sub -standard/defective. After 11.7.1997 the complainant did not follow the advice of OP No. 3 and incident had occurred mainly due to non -union of the bone. It was further urged that the Inter -locking Nail in question being an imported item, was not the goods'' within the meaning of Section 2(1) (i) of the Act. In support of this submission, reliance was placed on the decision in R.D. Goyal and Another v. Reliance Industries Ltd., III (2002) CPJ 1 (SC)=VI (2002) SLT 535=(2003) 1 SCC 81.

LET us first examine if in the aforesaid letter dated 23.2.1999, any acknowledgement of the Inter -locking Nail in question being sub standard/defective is made by Pfizer Inc. This letter (copy at page 42) was sent to the Counsel of the complainant with reference to the letter dated 28.1.1999 addressed to CEO, Pfizer Inc. Omitting immaterial portion, the letter reads thus: "In order for us to evaluate your claim, it is necessary for our engineers to examine the nail in a non -destructive manner. The examination by the sales representative only confirmed that the nail was a Howmedica nail. Also, we need to view the X -rays and medical reports of Mrs. Kaur before and after her surgery, as well as any other documents which would be relevant to enable us to evaluate your claim. As suggested in our previous correspondence, you can sent these materials to Ms. Rosemarie Walsh, Howmedica International Inc., Quality Assurance Department, Shannon Industrial Estate, County Clare, Ireland or to Capt. A.K. Dhingra who will sent the materials to the manufacturing location for evaluation. We cannot prepare any report until you comply with this request. We look forward to resolving this claim amicably and we hope that Mrs. Kaur''s health will continue to improve."

WITH reference to complainant''s another letter dated 27.2.1999, letter dated 8.3.1999 (copy at pages 45 and 46) was sent on behalf of opposite party No. 1 to the Counsel of the complainant. This letter being material, omitting immaterial portion, is reproduced below: "The visit of Mr. Love Sharma, Sales Officer based at Delhi was only to identify the nail is a Howmedica nail. As mentioned in our earlier letter dated October 15, 1998 a detailed inspection report can be furnished only by the manufacturer after examining the relevant documents and nail. You will appreciate in the absence of these details, it will not be possible for all concerned in this matter to respond to the issue you have raised. Hence, it is very important to sent following items to Howmedica International Inc. based at Shannon for examining the complaint - (a) The X -rays and reports thereof the patient -Pre -operation and Post -operation. (b) The nail is required for the Non -destructive testing Manufacturing Location. (c) Any other documents which would be relevant to enable them to examine your claim. You may hand over the X -rays and the nail to us for sending it to Howmedica International Inc., Ireland or alternatively you may send them directly at the following address: Ms. Rosemarie Walsh Howmedica International Inc. Pfizer Hospital Product Group Quality Assurance Department Shannon Industrial Estate Co. Clare, Ireland. Tel: No. 011 -353 -61 -475110 Fax No: 011 -353 -64 -474477. The above requirements have been reconfirmed by Pfizer Inc. in their letter dated Februaty 23, 1999 addressed to you and a copy marked to us. We are also attaching the copy of our letter dated October 15, 1998. Kindly note that the above steps are indicated without prejudice to the rights and contentions of ourselves and Howmedica International Inv. We make it clear that this should not be deemed to be an admission of liability on our part or that of Howmedica International Inv. We request you to send your response at the early date to enable us to take any action."

BOTH the letters dated 23.2.1999 and 8.3.1999 unmistakably go to show that it was not at all admitted by the manufacturer or the distributor that the Inter -locking Nail in question was sub -standard/defective. To resolve the claim amicably the Inter -locking Nail in question and X -ray reports, etc. in original were demanded which as is manifest from the complainant''s letter dated 9.3.1999 were never sent.

ON a conjoint reading of the written version filed by opposite party No. 3 and the cross -examination of complainant, it manifest that the complainant was instructed by opposite party No. 3 to attend the OPD on 21.5.1997 but she failed to attend it on that date, she attended the OPD of opposite party No. 3 on 11.7.1997 when her X -ray showed little callous and complainant was, therefore, advised to come back in a month''s time for a repeat X -ray and if the union was not found to be proceeding satisfactorily the complainant was warned that she may need Dynamisation. Still the complainant did not report back to opposite party No. 3 after 11.7.1997. Complainant alleges that she had severe pain at the place the Inter -locking Nail was inserted and was taken to LNJP Hospital on 26.6.1998 where X -ray was taken which revealed that the Inter -locking Nail had broken. Inter -locking Nail operation was conducted on 13.7.1998. No satisfactory evidence has been adduced by the complainant that she visited any other Doctor/Hospital between 12.7.1997 and 25.6.1998 for treatment which was absolutely necessary because of non -union of bone as detected by opposite party No. 3 on 11.7.1997. Inter - locking Nail was fitted as an aid for natural fracture healing process and to maintain meanwhile the anatomical position of the fractured bone. It could not be a substitute to the bone. Inter -locking Nail in question despite non -union of bone had remained intact for more than 13 months. From the unrebutted affidavit of said Klaus Dieter Nothacker, it is proved that the above manufacturer in regard to its products maintained quality system which met the requirements of EN ISO 9001: 1994 and EN 46001: 1996 and it was registered with Food and Drugs Association of USA at the relevant time. In absence of cogent evidence about the Inter -locking Nail in question being sub -standard/defective, it is difficult on said facts to return the finding of its being sub -standard/defective merely on ground of its having broken on 26.6.1998.

THIS brings us to the last limb of submission of the Inter -locking Nail in question not being the goods'' within the meaning of the Act. It was pointed out by Mr. Aditya Narain that the definition of goods'' occurring in Sale of Goods Act, 1930 has been made applicable in Consumer Protection Act, 1986 as also in Monopolies and Restrictive Trade Practices Act, 1969 and to include the items imported into India within that definition, the definition of goods'' has been amended in MRTP Act, 1969. This would show that the definition of goods'' as given in Sales of Goods Act does not include the imported goods''. Goods'' in Sales of Goods Act has been defined to mean "every kind of movable property other than actionable claims and money; and includes stock and shares, growing crops, grass, and things attached to or forming part of the land which are agreed to be severed before sale or under the contract of sale". Definition of goods'' as given under Section 2(1)(i) of the Act provides: " goods'' means goods as defined in the Sale of Goods Act, 1930 (3 of 1930)".

Para 11 at page No. 86 of the report of the decision in R.D. Goyal''s case (supra) being material is re -produced below - "The expression goods'' was defined in Section 2(e) of the MRTP Act to mean - 2.(e) goods'' includes goods produced in India, and in relation to any goods supplied, distributed or controlled in India, also includes goods imported into India,'' The aforesaid definition underwent an amendment in 1984 and again in 1991. Now it reads thus - 2(e) goods'' means goods as defined in the Sale of Goods Act, 1930 (3 of 1930), and includes - (i) products manufactured, processed or mined in India; (ii) shares and stocks including issue of shares before allotment; (iii) in relation to goods supplied, distributed or controlled in India, goods imported into India."

CONJOINT reading of the definitions of goods'' as given in Sale of Goods Act, 1930 and MRTP Act, 1969, would show that in the later Act the definition has been enlarged so as to further include the goods'' of the nature specified in Clauses (i), (ii) and (iii) of Section 2(e). In R.D. Goyal''s case (supra), it was held that the shares pending allotment could not be said to be goods''. In our view, the definition of goods'' given in M.R.T.P. Act cannot be applied to interpret the definition of the said expression in Sales of Goods Act and/or the Consumer Protection Act. Thus, even the goods imported would fall in the category of goods'' defined in Consumer Protection Act.

FOR the foregoing discussion, the complaint deserves to be dismissed being without any merit. Dismissed as such. No order as to costs. Complaint dismissed.