National Consumer Disputes Redressal
Atul Madan vs M/S Max India Ltd. & 7 Ors., on 3 September, 2024
NATIONAL CONSUMER DISPUTES REDRESSAL COMMISSION NEW DELHI CONSUMER CASE NO. 204 OF 2013 1. ATUL MADAN R/o D-404, Parasvnath Prestige, Sector-93A, NOIDA - 201304. ...........Complainant(s) Versus 1. M/S MAX INDIA LTD. & 7 ORS., Max House, 1, Dr. Jha Marg, Okhla Phase-III, NEW DELHI - 110020. 2. M/S MAX HEALTHCARE LIMITED, 1, Press Enclave Road, Saket, NEW DELHI - 110017. 3. DR. S. K. S. MARYA, CONSULTANT, ORTHOPEDICS, Max Super Speciality Hospital, 1, Press Enclave Road, Saket, NEW DELHI - 110017. 4. .DELETE VIDE ORDER DATED 18/07/2019 . . . 5. .DELETE VIDE ORDER DATED 18/07/2019 . . 6. M/S JOHNSON & JOHNSON, One Johnson & Johnson Plaza, New Brunswick, NEW JERSEY 08933 UNITED STATES OF AMERICA 7. M/S JOHNSON & JOHNSON LTD., 30, Forjett Street, MUMBAI - 400036. 8. M/S PURI CRAWFORD & ASSOCIATES INDIA (P) LTD., No. 5, 8th Floor, Jhaver Plaza Building, 1-A, Nungambakham High Road, CHENNAI - 600034. ...........Opp.Party(s)
BEFORE: HON'BLE MR. JUSTICE RAM SURAT RAM MAURYA,PRESIDING MEMBER HON'BLE MR. SUBHASH CHANDRA,MEMBER HON'BLE DR. INDER JIT SINGH,MEMBER
FOR THE COMPLAINANT :
Dated : 03 September 2024 ORDER
BEFORE :
HON'BLE MR JUSTICE RAM SURAT RAM (MAURYA), PRESIDING MEMBER
HON'BLE MR SUBHASH CHANDRA MEMBER
HON'BLE DR INDER JIT SINGH MEMBER
For the Complainant Mr M M Singh, Advocate (VC)
Mr Rajiv Ranjan, Advocate
For the Opposite parties Mr Sukumar Pattjoshi, Sr Advocate with
Mr Rahul Ray, Advocate
Mr Paras Chaudhary, Advocate
Mr Sarthak Garg, Advocate and
Mr Ram Krishnan Rao, Advocate for
Johnson
Ms Aakriti Goel, Advocate for NIA (VC)
Mr Yuvraj Singh, Advocate and
Mr Aditya Awasthi, Advocate for OP 1 & 2
Mr P Srivastava, Advocate for OP 3 (VC)
ORDER
PER SUBHASH CHANDRA
1. This complaint under Section 21 (a) (1) and 22 and other sections of the Consumer Protection Act, 1986 (in short, 'the Act') has been filed alleging negligence against the opposite parties with regard to a hip implant surgery conducted by opposite party no.3 in the hospital of opposite party no.2 using an artificial hip implant manufactured by opposite parties 4, 5 and 6. The complainant has prayed that the opposite parties (OP) be directed to:
Award compensation of Rs.1,56,79,385/- towards loss of income, mental agony, harassment, hardship suffered, pain endured, risk undergone, loss of income and status which all accrued as a direct result of an act of extreme medical negligence and deficiency in service.
Award legal costs to the complainants for an amount of Rs.2,00,000/- against the OPs; and Pass any other order that this Hon'ble Commission deems fit and proper in the facts and circumstances of the complaint.
2. An amended memo of parties was filed by the complainant which was taken on record. Parties led their evidence by way of affidavit and filed their written version. Rejoinder and reply has also been filed by the parties. Learned counsel for all the parties also filed their written synopsis of arguments along with cases laws relied upon by them.
3. The relevant facts of the case, in brief, are that the complainant who was employed as Vice President in a real estate sector private company was suffering from pain in the hips and after conduct of various tests, had been diagnosed by OP No.3 to be suffering from 'osteoarthritis bilateral hip joint' and was advised 'proximal total hip replacement surgeries on both hips'. On 26.07.2007, OP no. 3 implanted the complainant with DePuy ASR (Total Acetabular I implant) in the left and right hips along with DePuy ASR XL (femoral implant), DePuy Proxima Hip (Duofix Stem) and DePuy ASR (Taper Sleeve Adaptor), (hereinafter referred to as "ASR Implants') for both the hips. According to the complainant the implants were done in OP no.2 hospital through OP No.3, surgeon. Despite the complainant adopting all precautions advised and undertaking the exercises prescribed by OP no.3, the pain in the complainant's left hip did not subside and, on the contrary, increased during 2011-12. He submits that he was consequently removed from his job in April 2008 and had to seek another assignment in September 2008 followed by yet another assignment in April 2009 which caused him financial loss since he had to accept positions which paid him less on account of his inability to work as a consequence of the pain he was experiencing following the hip implant surgery. Eventually he had to become self-employed, and his income dropped substantially. The complainant submitted that despite repeated consultations with OP nos.2 and 3 during the period 2008-12 on as evidenced by visits to OP no.3 in OP no. 2 hospital on 18.01.2008, 05.07.2008 and 15.11.2008 and 02.03.2012 and the advice of various medications by them, he was forced to obtain a second opinion from a specialist Orthopedic Surgeon, Dr Vijay Bose of Apollo Hospital, Chennai in 2011-12. The complainant submitted that on 22.08.2012, to his utter shock and surprise, he was informed by Dr Vijay Bose that the ASR Implant by DePuy had been recalled by OP nos.4 to 6 in 2010 as they had a higher than a normal failure rate and were defective. Dr Bose also informed the complainant that the ASR Implant had also been wrongly implanted in the left hip and therefore, required immediate revision surgery.
4. Consequent to this advice, the complainant underwent revision surgery on his left hip on 18.09.2012 at the Apollo Specialty Hospital, Chennai. The complainant was discharged on 25.09.2012 from the said hospital.
5. The complainant averred that even after the recall of the ASR Implant in 2010 by OP 5 through a letter to the Government of India, OP nos.1 to 3 deliberately did not inform the complainant through any intimation of the recall and did not offer any revision surgery. It is contended that this was medical negligence on their part since they manufactured, marketed and sold a defective product through OP nos. 4 to 6. The complainant sent a legal notice dated 10.01.2013 to OP nos.1 to 3 which was acknowledged and replied to by them on 13.02.2013. Another notice dated 10.01.2013 to OP nos. 4 to 6 was also replied to by them 18.02.2013. The complainant then filed two complaints against OP no.1 and others (CC no. 40/2013) and against OP no.4, DePuy Orthopedic and others (CC no.41/2013). The same were permitted to be withdrawn by this Commission vide order dated 04.03.2013 and a consolidated complaint was permitted to be filed. Hence the present complaint.
6. The complainant has alleged that the OPs failed to act diligently with due care and caution which was evident from the fact that the hip implants manufactured and marketed by them had 'more than normal failure rate'. Despite this information being available with them, it is argued, OP nos. 4 to 6 willfully introduced the hip implant product in the market and could not now shirk their liability under the garb of recall of the product.
7. It was also averred by the complainant that it was evident from the report of Dr Vijay Bose that OP nos. 1 to 3 had been negligent in that the surgery conducted by them on the complainant was defective and had the potential of causing permanent bone damage. It was also contended that despite repeated consultations with OP nos. 1 to 3 till 2012 relating to post-operative complications, OP nos. 2 and 3 failed to inform the complainant and intentionally concealed this fact from the complainant. Therefore, OP nos. 1 to 3 had erred in implanting the hip implant despite being aware of its failure rates, were liable for an improperly implanted prosthesis and even after being aware of the recall of the implant in 2010, failed to inform the complainant and offer a revision surgery. Consequently, the complainant suffered physically, mentally, financially and lost three jobs.
8. Dr Vijay Bose, vide his e-mail dated 23.08.2012 to the complainant, diagnosed that that "left femoral implant is loose and will require revision to sort out the pain. This must be done reasonably early as it may cause bone destruction if left out for too long". The surgery was done on 18.09.2012 as per the discharge report from Apollo Hospital, Chennai on 25.09.2012. It was mentioned that "Complex Revision with S-Rom Stem surgery" was conducted following the diagnosis of left THR implant failure. The Discharge Summary had also noted that the left hip was shortened by 2 centimeters.
9. The complainant has filed this complaint, inter alia, on the grounds that despite the ASR Implants he was prevented from performing his duties and was rendered jobless on account of excessive pain due to negligence in the implant of a defective and faulty ASR Implant. He underwent substantial pain, mental agony and risk in undergoing a revision surgery as a consequence. Despite prior knowledge regarding the recall of the ASR Implants, OP no.1 to 3 failed to inform the complainant of such a recall and kept on advising inconsequential medication and therapies on being consulted. OP nos. 2 & 3 failed to mitigate his problems requiring him to visit them on several occasions in 2008 which gives credence of his complaint that the surgery did not yield the desired results including in the reduction in pain. It is also alleged that OP no.4 - 6 did not ensure that the hospital and Doctor responsible for such implants were kept informed to enable them to intimate patients who had received such implants and to enable them to undergo revision surgeries in order to mitigate their pain and sufferings. It was contended that OP nos.1-3 had been provided with X-ray reports which showed a faulty operation in the left hip with a recalled product which was ignored and therefore, OP no.3 failed to fulfil the duty of a doctor which directly indicates a callous and negligent manner of handling the complainant's case.
10. It is also alleged that OP nos. 4 - 6 did not inform the complainant about the possible side effects of ASR implants such as metal chaffing, permanent nerve and muscle damage, pain and swelling which amounted to gross medical negligence on the part of OP nos. 1 - 3. Not conducting a revision surgery by the OPs resulted in complainant losing his job, thereby resulting loss of income and position in society.
11. It is argued that the cause of action first arose on 26.11.2007 when the hip replacement surgery was performed by OP nos. 2 and 3 and continued subsequently, when, post operation, the pain continued and thereafter, when the ASR Implant was recalled by OP no. 4-6 in 2010. It is also submitted that the cause of action continued during various consultations of the complainant of OP nos. 2 and 3 and on 22.08.2012 when the complainant learnt about the recall of the ASR Implants by OPs 4-6. According to the complainant, the cause of action continued thereafter when a legal notice was served on the opposite parties on 10.01.2013.
12. The complainant has claimed loss of income amounting to Rs.1,18,71,852/- for the period 2009-10 to 2013-14 based upon his income tax return as per his salary and perquisites which amounted to Rs.55,000/- per month as below:
S No Assessment Year Income from salary (Rs) Perks
1.
2006-2007 3,46,807
2. 2007-2008 8,31,972 3,30,000
3. 2008-2009 10,38,951 6,60,000
4. 2009-2010 9,47,328
5. 2010-2011 5,93,364
6. 2011-2012 8,89,800
7. 2012-2013 13,71,026 Assessment Year Actual Income Expected Income (with perks) Loss 2009-2010 9,47,328/-
23,50,000/-
14,02,672/-
2010-2011 5,93,364/-
30,00,000/-
24,06,636/-
2011-2012 8,90,800/-
36,50,000/-
27,59,200/-
2012-2013 13,71,026/-
43,00,000/-
29,28,974/-
2013-2014 Not Yet Filed 49,50,000/-
23,74,370/- (Approx., average) Total 46,81,492/-
1,82,50,000/-
1,18,71,852- Loss of Income Rs.1,18,71,852/-
For permanent damage in the resume due to gap in employment leading to loss of income Rs.20,00,000/-
Mental agony, loss of social status and harassment Rs.10,00,000/-
Physical pain because of the negligence by OPs Rs.10,00,000/-
Legal Cost Rs.2,00,000/-
Total 1,58,79,385/-
13. Reliance has been placed on the judgment of the Hon'ble Supreme Court in Kusum Sharma Vs Batra Hospital and Medical Research Centre, AIR 2010 SC 1050, wherein it was held that "interest and welfare of the patients have to be paramount for the medical professional" and on this Commission's judgment H S Sharma Vs Indraprastha Apollo Hospital, II (2007) CPJ 21(NC) wherein it had been observed that post-operative treatment was also important in surgery of any kind.
14. On behalf of OP no.1, it was contended that it was neither a necessary nor a proper party to the complaint since OP no.1 and OP no.2 were separate legal entities and OP no.1 was neither associated nor involved at any time in the medical procedure undergone by the complainant. OP no.1 stated that it does not provide any operational/ medical services relating to health care and hence, the question of providing any medical services to the complainant did not arise. It was also submitted that the complainant had not made any specific allegation of medical negligence qua the OP no.1 and it was contended that the complainant did not dispute that no medical services were provided to it by OP No.1 in his Rejoinder to OP no.1's Reply. It was also contended that it had been impleaded based on the misconception that it was the parent company of OP no.2 whereas OP no.1 was only a joint venture partner holding 49.7% share and was not involved in the operational activities of OP no.2. It was submitted that as per settled law, the legal relationship between the holding company and a subsidiary was that of two distinct legal persons, as held by the Hon'ble Supreme Court in Vodafone International Holdings BV vs UOI, (2012) 6 SCC 613 and in Arun Kumar Mangalik vs Chirayu Health and Medicare Pvt. Ltd., and Anr., (2019) 7 SCC 410 wherein the Apex Court had held that the Director of a hospital should not be made liable for medical negligence by doctors of that hospital. It was contended that there was no consumer-service provider relationship between the complainant and OP No.1 as required under the Act and therefore, it had been wrongly impleaded in these proceedings.
15. OP no.2 contended that there had been no negligence in the treatment of the complainant or any deficiency in service on its part and that the complaint deserved to be dismissed on the ground of limitation. It was submitted that the complainant had been under psychiatric treatment under Dr Ajay Pal Singh Psychiatrists for Bipolar I disorder for 4 years in the OP no.2 hospital prior to admission on 28.11.2007. As per medical records, the patient had progressed well after surgery and was discharged in a stable condition on 03.12.2007. The complainant had had no complaints regarding the surgery 03.02.2012 when he was advised X-ray in the OPD of OP No.2 and after review, was advised revision surgery if the pain did not subside. Revision surgery was conducted only on the left hip (subsequently in Apollo Hospital, Chennai) and it was stated that there was no nexus with the surgery performed by OP no.2 on 26.11.2007 which was almost 5 years prior to the revision surgery.
16. It is also contended by OP no.2 that in his final written submission dated 10.04.2024, the complainant has stated that the complaint has been preferred against "the faulty and careless implant of ASR Hip Implants, OP nos. 1-3 which were faulty, suffering from defect and were detrimental and health of patients and for which reasons they were recalled by OP no.4 in the year 2010". According to OP no.2, the case of the complainant is that the implants manufactured by OP no.4 were faulty for which reasons they were recalled and therefore, OP no.2 and 3 had been negligent in using the defective implants resulting in pain which finally led to a revision surgery in 2012. While stating that the complainant has not questioned the treatment or alleged any negligence in the conduct of the surgery by OP Nos.2 and 3 other than the use of an allegedly defective implant manufactured by OP No.4, it has not been disputed that both the hips had been successfully operated and replaced on 26.11.2007 by OP no.3 at OP no.2 and there had been no allegation of pain and discomfort post-surgery and discharge of the complainant from the hospital. It was stated by OP no.2 that while the surgery was conducted on 26.11.2007 the recall of the implant by OP no.4 was in 2010. It was also submitted that there was no complaint with regard to the implant in the right hip which indicated that there was no inherent defect in the implant itself. In view of these admitted facts by the complainant, the recall of the implants in 2010 cannot be relied upon to argue that the implants could not have been used for surgeries by OP no.2 and 3 in 2007, which was almost three years prior to the recall. On the contrary, it was stated that at the time of the surgery the implants used were the latest prostheses and were supported by a world-renowned company and approved by the Drug Controller of India. Thus, it cannot be stated that there was any medical negligence or deficiency in service in using such implants in 2007. It was argued that no negligence in the treatment of the complainant as also in the use of the implant in the 2007 by OP Nos. 2 and 3 had been found by the Medical Board of Experts at Maulana Azad Medical College, Delhi vide their report dated 27.07.2022. It was also pointed out that this medical Expert Opinion was pursuant to the complainant's own request to this Commission. As per this report, it had been opined that, "the surgeon has replaced the hip in 2007 with ASR DePuy, which was routinely practiced in India and abroad during the said period. The implant was recalled in 2010 because of implant design. The surgeon was rightly justified in using the implant for the above surgery." Therefore, the complaint deserves to be dismissed.
17. It is contended by OP no.2 that the complaint was an afterthought and was barred by limitation since the complainants own case was that the surgery was performed on 26.11.2007 at the hospital whereas the complaint was filed on 28.06.2013. The complaint was filed with the intention to seek unjust enrichment at the cost of the opposite parties. The complainant had admitted that he became aware of the alleged defect in the implants and their recall on 22.08.2012, i.e. nearly five years after the surgery from one Dr Vijay Bose of Apollo Hospital in Chennai. According to OP no.2 this indicated that the implants had functioned for almost five years and the complainant had no complaints till then. It was contended that the cause of action could also not be extended to 2012 on account of the discovery of the fact of recall of the implants or till the date of revision surgery since it was the complainant's case that he was in pain since November 2007 when surgery was conducted and was unable to walk for long durations and had to lose his job in April 2008. It was argued that the cause of action, therefore, needs to be reckoned from 2008 and not 2012, when the complainant came to learn that the hip implant had been recalled. Reliance was placed on judgment of the Hon'ble Supreme Court in V N Shrikhande vs Anita Sinha Fernandes, AIR 2011 SC 212. It was submitted that the e-mail dated 22.08.2012 from Dr Vijay Bose intimating that the ASR Implants had been recalled and revision surgeries were being supported by the manufacturer lacked evidentiary value since no affidavit had been filed under Section 65 of the Evidence Act, 1872. It was similarly argued that the web based documents relied upon by the complainant being electronic records could be relied upon only after they were proved.
18. It was contended, without prejudice, that the ASR Implants had not been negligently implanted and that the communication from Dr Bose had stated that the ASR cup was exposed and found to be in good position and hence the problem was only due to loosening of stem, which was expected, due to the failure of the metal-on-metal articulation. It was argued that this correspondence did not mention any negligence or wrong implantation. The complainant had also accepted all associated risks of surgery through a signed informed consent form dated 25.11.2007 and had consented for the proposed procedure voluntarily and he visited the hospital only after he became aware of the alleged defect in the implants and recall of 22.08.2012 which was nearly five years after the surgery.
19. OP no. 2 stated that in all cases of hip implants where the device had been withdrawn from the market for any reason, the protocol prescribed was that no investigations were required in the absence of pain where implants were performing well and in cases of pain around hip, investigation regarding cause of pain including clinical examination involving cobalt, chromium and iron levels was prescribed. Revision surgery was advised if blood ion reports were abnormal or the pain was not settling. It was argued that in the instant case there was no complaint till 02.03.2012, i.e. 4.5 years after the surgery. Despite advice for X-ray and review, the complainant did not comply and has not produced any documents to establish that he was following up with OP No.2 between 2008 to 02.03.2012. The complainant had sought an Expert Opinion from the Maulana Azad Medical College, New Delhi which had held that there was no negligence in the conduct of the surgery on the complainant by OP nos. 2 and 3 and therefore, no compensation was payable.
20. As per OP no. 2, the absence of documentary evidence regarding pain or discomfort after the surgery in November 2007 till March 2011 indicated absence of any nexus between the ASRTM Implants and the pain and the alleged loss of jobs due to such pain. Further, the removal of the complainant from the job was not attributable to the OPs but could also be due to the complainant's bipolar disorder from which he was suffering for 4 years prior to the surgery and was under medication for. It was argued that the complainant had been reimbursed with the cost of the revision surgery by OP 4 - 6 through M/s Puri Crawford & Associates India Pvt. Ltd., for Rs. 25.00 lakh as admitted by the counsel for the complainant.
21. OP no.2 contends that complainants have failed to establish manufacturing defect under Section 13 of the Act through any laboratory report as was mandatorily required to establish a manufacturing defect. Therefore, no compensation was payable to the complainant.
22. on behalf of opposite party nos. 4, 5 and 6 preliminary objections were taken that (i) the complaint was not maintainable on ground of pecuniary jurisdiction since the cost of the ASR Implant in 2007 was much less than the relief claimed and the revision surgery carried out in 2012 was free of cost and therefore the claim of Rs.1,58,79,385/- was an inflated figure only to approach this Commission; (ii) the cause of action dated to prior to the implants since complainant had suffered identical ailments and following the implants the pain had been experienced only in the left hip and no complaint had been made with regard to the right hip, which indicated that there was no inherent defect in the ASR implant itself. Therefore the cause of action, if any, could have only arisen in April 2008 when the complainant lost his job and the complaint was filed far beyond the time prescribed under section 24A of the Act; (iii) deficiency in service under section 2 (1) (g) of the Act involved any breach of legal or contractual obligation undertaken to be performed which had not been established and the complaint was based on fabricated and contradictory facts; (iv) there was misjoinder of parties since OP nos.5 to 7 had been impleaded although they have no role; (v) the relief sought was towards remote and indirect losses such as loss of salary due to loss of job because of pain on account of an allegedly defective implant and therefore, this Commission lacked jurisdiction to grant relief and (vi) the complaint was not in the nature of a consumer dispute since the alleged inherent fault had not been substantiated through any evidence on record, the onus of proving which lay on the complainant.
23. On merits, it was submitted that OP no.5 was a company incorporated in India in 1986 under the Companies Act and was engaged in importing and exporting orthopedic implants. OP no.5 was a subsidiary of OP no.4, DePuy Orthopedic Inc., USA. OP no.4 was neither the manufacturer nor the importer of the DePuy ASRTM XL Acetabular System and DePuy ASRTM Hip Resurfacing System in India and hence, there was a misjoinder of parties in the complaint. OP no.5 imported and marketed these orthopedic implants including hip implants. OP No.4 was a group company of Johnson & Johnson and OP no.6, Johnson & Johnson Ltd. was part of the group companies of OP no.5. OP no.6 was stated to be wrongly impleaded as a party.
24. OP no.5 contended that DePuy ASRTM Hip Resurfacing was launched in UK and had a CE certification which was the manufacturer's declaration of product's compliance with the essential requirements of the European Health, Safety and Environmental Protection Legislation and authorized its sale. Based on DePuy International Ltd., Number One, White Rose Office Park, Millshaw Park Lane, Leeds LS 110EA (in brief 'DePuy UK') obtaining an import license from the Drug Controller of India (DCGI) License no.MD-132-83 dated 15.12.2006 (renewed on 18.02.2010 with validity till 31.10.2012) under the Government of India Regulations of 2006, OP no.5 commenced import and marketing of hip implants manufactured by the parent company in 2004. DePuy ASRTM XL Acetabular System was launched in the USA in 2005 with approval of the United States Food and Drug Administration (USFDA) for medical devices for manufacturing, performance and safety. The hip joint was based on a ball-and-socket joint comprising a femoral head and cup shaped, hollow socket called acetabulum. Hip implants were made from various materials, such as metal, ceramic and polyethylene and were used in various combinations of these materials. Due to movement of the femoral head in the acetabulum, there was a "wear rate" resulting from friction which determined the life of the hip implant or prosthesis. It was stated that all prostheses had a finite life span as they wear over time. In the case of hip implants, due to wear there was production of debris that leads to aseptic loosening of the prosthesis resulting in pain raising the possibility of revision surgery. A Total Hip Replacement (THR) required replacement of both the femur and acetabulum depending on medical condition and the consent of patient. The complainant had been implanted a metal-on-metal DePuy ASRTM XL Acetabular.
25. Countries like Australia and UK had set up National Joint Registries (NJR) to collect data from the patients and hospitals with regard to joint replacement surgeries including the revision surgeries to inform health care professionals, Governments, orthopedic companies and communities on the various aspects of replacement. In February 2010 the Australian Registry indicated a higher-than-expected revision rate of 8-9% at three years for some components viz., the ASR acetabular cup and unipolar femoral head used with DePuy Stems in THR and issued an Urgent Field Safety Notice to surgeons/ clinicians on 08.03.2010. The same was informed to the Drug Controller General of India also. The UK Registry also noticed that the data for the five-year revision rate for the DePuy ASRTM XL Acetabular System was approximately 13% as against 10% or less at 10 years. DePuy UK voluntarily decided to recall the product from the market globally vide recall notice dated 24.08.2010 and informed the DCGI of India on the same date. The notice required the surgeons not to implant the ASRTM devices and to inform the patients who had received the ASRTM system of the recall and to return for a follow-up visit. Thereafter, a reimbursement process and documentation was initiated in March 2011 to guide patients and Puri Crawford and Associates India Pvt., Ltd. was engaged as the Claims Management Organization in this regard.
26. According to OP no.5, from 2004, when ASRTM devices were launched, till voluntary recalls in August 2010, 4700 ASR surgeries had been conducted of which approximately 700 patients registered under the remedial and reimbursement process and approximately 100 patients underwent revision surgery.
27. According to OP no.5, the recall of a product does not tantamount to the product being 'defective'. It was stated that in case of the DePuy ASRTM XL Acetabular System, OP no.4 had adhered to all legal procedures and guidelines and had obtained all the requisite approvals and licenses from the DCGI. The complainant, while alleging that ASRTM Implants in question had deteriorated his medical condition, had failed to prove that such deterioration was the result of any negligence on the part of OP nos.4 - 6 or of any unfair trade practice or any deficiency in service. The onus of proving this lay on the complainant which had not been discharged. It was averred that the surgeon performing the surgery was required to undertake due care and diligence and conduct the surgery after explaining the details of the risks and obtaining the consent of the patient. It was also stated that various documents such as Warning Statement and Instruction Use Manual and Adverse Reactions had been indicated along with the supply of the implant. These included details of the adverse effect relating to metal-on-metal (MoM) implants as was the case in the complainant's implants. According to OP no.5, it was only an importer and the marketer and it was for the surgeon to decide which implant suited the patient, including the size and type, based on the medical condition of the patient.
28. According to OP no.5, the complainant's allegation ignored the fact that the implants were imported and supplied by OP no.5 with license from the DCGI and that these were neither faulty nor suffered from any manufacturing defect as was evident from the fact that despite the implants in both his hips, he only experienced pain in the left hip. Admittedly, there was no need for revision surgery of the ASRTM hip implant in the right hip. Therefore, it could not be said that there was a manufacturing defect. The complainant had other medical issues such as diabetes which had delayed his surgery in the first place. The conduct of the complainant in not visiting the doctor despite his complaint for pain after the surgery for a long period indicates that the complaint was fabricated.
29. According to OP no.5, while the complainant asserts that he underwent revision surgery on the advice of Dr Vijay Bose of Apollo Hospital, Chennai, he has not disclosed his exact medical condition. All contentions regarding monetary loss resulting from loss of employment and subsequent monetary loss due to revision surgery is contested. The cost of the revision surgery was stated to have been reimbursed on behalf of OP No.5 by Puri Crawford & Associates India Pvt. Ltd.
30. It is stated that the DCGI had approved the implant based on the license granted and it had not been established that the product was not in conformity with either the requirements of the license or the approval of the USFDA. It is submitted that the complainant's allegation that OP nos. 4 and 5 did not ensure that the hospital and doctors inform the recipients of the implants is also contested on the ground that OP nos.4 and 5 had issued a safety notice as well as the voluntary recall notice which included express instructions that the doctors reach out to the patients and inform the contents of the notice. This was also evidenced by the fact that the notices were sent to individual doctors and surgeons including the DCGI and the supply of ASRTM implants was discontinued. A mitigation and claims procedure was instituted through a separate agency, viz., Puri Crawford & Associates India Pvt. Ltd.
31. As regards the compensation claimed, OP no.5 submits that the complainant had calculated his expected income without any reasonable explanation of its basis. It is also submitted that the complainant had not provided any evidence to support his claim for loss of salary, loss of job or to support the contention that the change of job was due to the ASR implants. It is averred that the Hon'ble Supreme Court has in various judgments held that in a claim of compensation there must be a balance between inflated and unreasonable demands of the claimant and the submissions of the opposite party.
32. On the issue of the hip implants being defective, OP no.5 in its common arguments contended that the Ministry of Health Family Welfare (MoH&FW) had constituted on 08.02.2017, through the DCGI, an Expert Committee under Dr Arun Kumar Aggarwal, Professor of ENT, Maulana Azad Medical College, New Delhi. The Committee submitted a report dated 19.02.2018 and concluded that OP no.5 had recalled a product whose revision rate was 12-13% which was almost 2½ times the revision rate of 5%. It noted that the ASRTM Hip Implant was removed from the Australian market in December 2009 as per the data of the Australian Registry and there appeared to have been suppression of facts by OP no.5 to the Central Drugs Standard Control Organization (CDCSO). It also observed that OP no.5 should have informed the removal of the ASRTM Implants from the Australian market which was only learnt from the intervention of the TGA. It noted that in Australia, Class Action had been settled for US $ 250 million plus interest and legal costs which had been upheld by the Federal Court of Australia. It noted that the premature failure of the ASRTM artificial hip implant put the patients to severe consequence of pain, difficulty in walking and disability to engage in normal/ routine activities. It observed that revision surgery was a major operation entailing risk of infection, loss of bone and other serious complications affecting the patient's ability to work or engage in daily activities. It therefore recommended corrective measures including reimbursement programmes, revision surgeries etc.
33. OP no.5 M/s Johnson & Johnson challenged this report vide Writ Petition (Civil) no.13395 of 2018 before the Delhi High Court. The basis of this challenge was that the Expert Committee was vires the existing provision of law, in particular the Drug Control Act and Rules thereunder as it was set up to investigate the actions of the opposite parties pursuant to the pre-ordained conclusion of fault which was not its mandate. It was contended that the ASR Implant was a complex product involving modular components and was dependent on its placement in the body through complex pre-operative, operative and post-operative procedures based on the anatomical make-up of the patient apart from existing comorbidities, if any. It was also contended that the Expert Committee was neither a Drugs Technical Advisory Board (DTAB) or a Drugs Consultative Committee (DCC) nor a statutory committee of enquiry but an ad-hoc committee with no statutory basis. Vide its order dated 20.03.2023, the Delhi High Court observed that if the report of an Expert is sought to be relied upon before any other court or forum, then the concerned court would consider the objections of the OP against this report. In furtherance of the recommendations of the Expert Committee, the MoH&FW constituted another Technical Committee under Dr R K Arya, Director Sports Injury Centre ("Arya Committee") to examine the issues related to payment of compensation to ASRTM Hip Implant patients and to provide recommendations regarding quantum of compensation to MoH&FW in regard. The Arya Committee, as part of its Report, recommended a formula for determining compensation based on a basic amount of Rs.20 lakh multiplied by the risk and age factor, fair risk factor was linked to the disability percentage along with Rs.10 lakh towards non pecuniary damages. It also prescribed a process for payment of compensation. Vide Press Note dated 29.11.2018, the Government of India adopted the Arya Committee recommendations and formula and the MoH&FW issued orders dated 30.11.2018 to OP no.5 to pay compensation to patients who had been implanted with the ASRTM Hip Implants and to submit claims before it. OP no.5 challenged this order directing individuals to be compensated through Writ Petition (Civil) no. 3523 of 2019 and Writ Petition (Civil) no.4691 of 2019. However, OP no.5 voluntarily offered payment of Rs.25 lakh to all patients who had undergone revision surgery subject to verification.
34. OP no.5 contested the findings of the Expert Committee and argued, based on the Preface and Terms of Reference, that the reference was not for examining the patient or to arrive at a finding as to whether the product was defective; rather, it was for devising a procedure for dealing with issues arising out of implants and to create a mechanism for reviewing the medical management and compensation provided by OP no.5 to the patient. It was contended that the Expert Committee report was not a piece of evidence to establish that the implant was per se defective since they did not examine any patient or test a single implant. According to OP no.5, it had explained to the Expert Committee, vide letter dated 06.05.2017, that there was no definitive product design or material which was the root cause for the higher revision rate of the implant. According to OP no.5, the life of a joint replacement implant system depended on a multiplicity of factors, including adherence to surgical technique, patient's selection (bone quality) and rehabilitation procedure. It was argued that each revision surgery was a unique case which required specific action based on the device design and manufacture, surgery, including the surgeon and surgical technique and patient, including comorbidities and post-surgical activity level. The Expert Committee report was contested on the grounds that it was based on conjecture and surmises drawn from pre-supposition of fault and was biased. According to OP No.5, the mandate given to the Expert Committee was a pre-concluded fault and it decided on the weak testimony of two Experts which was speculative. It was submitted that while the Expert Committee had a sought reports from multiple regulatory agencies across the world, it did not receive a single response and the Australian Regulatory Agency TGA had opined that "the higher rates of revision were most probably due to the technical complexity of correctly fitting the device" which did not imply any manufacturing defect.
35. We have considered the arguments and written submissions of the counsel for the parties and considered the records carefully.
36. On the preliminary objections taken by the OP nos. 4 to 6, it is seen that the complaint meets the pecuniary threshold under the Act prescribed for the Commission in the light of the judgment of this Commission in CC no. 97 of 2016 in Ambrish Kumar Shukla vs Ferrous Infrastructure Pvt. Ltd., decided on 07.10.2016 and Renu Singh vs Experion Developers Pvt. Ltd., in CC no.1703 of 2018. As regards the cause of action, in view of the revision surgery which is 18.09.2012 the complaint filed on 28.06.2013 is within the period of limitation prescribed. As for deficiency in service, it is evident that following the recall of the ASM Implants for a higher than normal failure rate and the necessity for a revision surgery being recommended by the OP nos. 4 to 6 in view of the fact that he continued to experience pain despite the implant surgery on 26.11.2007, the complainant was entitled to seek compensation. In view of the amended Memo of Parties having been taken on record, the issue of misjoinder of parties does not arise. The complaint was, therefore, considered maintainable under the Act and was heard on merits.
37. The complainant's case is that he had been implanted with a device manufactured and marketed by the opposite parties 4 - 6 by OP no. 3 in OP no.2 hospital which had later been recalled by them on the grounds of a higher-than-normal rate of failure and that the same had not been communicated to it as per the required protocol after due enquiry by the relevant agencies of the Government of India. He was kept in the dark about the need for revision surgery at the cost of OP no.5 which came to his knowledge only during the course of obtaining a second opinion in view of persistent pain in his left hip. On account of the incidence of pain and resultant discomfort he had suffered loss of income in view of loss of jobs and had to become self-employed. He has therefore claimed compensation of Rs.1,58,79,385/- including legal costs of Rs.2.00 lakh against the OPs.
38. On the other hand, the case of OP no.1 is that it is not party to the issue being a Joint Venture (JV) partner in OP no.2, the Hospital where the surgery was carried out. OP no.3, the doctor has contended that the surgery was correctly conducted and as on the date of the implant, the ASR Acetabular was duly licensed and accepted as one of the best implants. On behalf of OP nos.4 to 6, through detailed arguments it has been contended that the implant had been voluntarily recalled after a higher-than-normal rate of failure was reported in Australia and the UK. This was followed by the establishment of a process of intimating the hospitals and surgeons conducting hip replacement/ implants (THR) through detailed advisories and thereafter instituting a mechanism for revision surgery at its cost in cases where patients continued to report difficulties/ increased incidence of pain consequent to the initial implant. It was contended that there was no inherent manufacturing defect in the implant and that the voluntary recall was limited to only those cases where post-operative difficulties were reported by patients. In other words, it is their case that the product per se was not flawed but on account of a higher than normal incidence of failure due to either metallosis and higher wear rate, the implants had caused some patients with implants to continue to experience pain and other medical problems. The conclusions of the Expert Committee were challenged before the Delhi High Court on various grounds including its constitution by the Government and its terms of reference which pre-supposed that the product was defective.
39. From the records, it is manifest that the complainant has not brought on record details of his medical problems consequent to the surgery on 26.11.2007 when a bilateral hip implant was conducted on him in OP no.2 hospital by OP no.3 doctor except evidence of having consulted OP No.3 in OP no.2 hospital on 18.01.2008, 05.07.2008, 15.11.2008 and 02.03.2012. It is his case that despite the bilateral THR and the assurances that the pain experienced by him would subside or go away, the same did not happen insofar as the left hip was concerned. It is evident that he undertook repeated consultations to mitigate the experiencing of pain in the left hip. However, the submission of the complainant that this impacted his employment prospects is not established. However, the fact that he sought a second opinion from another expert in the field, Dr Vijay Bose of Apollo Hospital, Chennai does establish that all was not well with regard to the THR implant in his left hip. It is also manifest that the revision surgery that was advised by the said doctor Dr Vijay Bose was not contested by the OP nos. 4 to 6. The cost of the revision surgery is stated by OP no.5 to have been defrayed by it though no evidence is brought on record. It is therefore apparent that the complainant did, in fact, suffer on account of the left hip THR using ASRTM Implant. There was no need otherwise for the revision surgery costs to be undertaken to be met by OP no.5.
40. It was further contended by OP no.5 that no doctor's prescriptions for visits on 18.01.2008, 05.07.2008 and 15.11.2008 and 02.03.2012 had been produced by the complainant, although the receipts of consultation had been brought on record indicated that the complainant did not follow up with the operating surgeon following the implant surgery.
41. OP no.5 has contended on behalf of the opposite parties that the voluntary recall of the ASRTM Implants did not imply that the implant itself was defective. It was submitted that in view of the fact that only 12 - 13% of the implants had been reported to be the cause for continued problems for some patients and in some cases there were other factors including comorbidities involved, the fact that it was higher than the normal 5% failure rate had lead it to voluntarily recall the product in Australia and UK and subsequently in India. It had also, thereafter, advised hospitals, surgeons and other stake holders of the same and instituted a mitigation programme involving revision surgery and certain reimbursements. From the above, it is evident that the opposite parties accepted the fact that there were certain short comings in the product although it was not of a magnitude that warranted a full recall of the product itself.
42. Counsel for the opposite parties also referred to the judgment of the Superior Court of the State of California in Sandra Ellis, Loren Kransky and Others vs DePuy Orthopedics Inc., dated 22.03.2013 (Case no. BC 456086 and of the Court of Appeal of State of California in CA/2/7 in Kransky vs DePuy Orthopedics dated 21.07.2016 (Case no. B 249576). This case had been cited by counsel for the complainants in other related matters and pertained to a Class Suit by over a hundred individuals (including Loren Kransky) pertaining to DePuy ASR Acetabular Hip System and DePuy ASR Hip Resurfacing System. In this case recipients of the ASR implants had experienced pain, lack of mobility metal sensitivity, loosening and misalignment of the prosthesis of the infection, dislocation, bone fracture and high metal ions in the blood, cyst formation and revision surgery to explant the ASR Implant and replace it with a non-defective product had been undertaken. The ASR Implants had been recalled in August 2010, although it was alleged that the defendant DePuy Orthopedic was aware of the defects in the Implants and were therefore, liable for the agony and discomfort caused to the petitioners. It was also alleged that the defendant failed to adequately warn the patients of the potential risks and instead claimed that the hip implants will last 15-20 years. The Superior Court of California, vide judgment dated 21.03.2013, held that the DePuy ASR XL Implant was defective on account of its design and the defective design caused injury to the plaintiff Loren Kransky. It was also held that the device was sold in a defective condition and that DePuy Orthopedic failed act as reasonable medical device manufacturer. However, it was held that the defendant's failure to act in such a manner did not cause injury to Kransky nor was the injury due to malice of DePuy Orthopedics. Damages of US $ 8260790.95 with cost were awarded, although no punitive damages were awarded.
43. In the appeal filed by the DePuy Orthopedics in the Court of Appeal of State of California in CA/2/7, it was held that the trial court did not abuse its discretion and affirmed the compensatory damages awarded.
44. While challenging this submission, it was argued on the part of opposite parties that these judgments were between the parties and were based upon their own evidence and as such were neither admissible nor reliable. However, this argument is not liable to be accepted as the judgment relates to similar ASR XL Hip Implant, metal-on-metal devices manufactured DePuy during the same time and as such is considered relevant and admissible under Section 13 of the Evidence Act 1872 as held by the Bombay High Court in Mohammed Amin vs Hasan, ILR 31 Bombay 143, the Hon'ble Supreme Court in Bhagwati Prasad Shah vs Dulhin Rameshwari Kuer, AIR 1952 SC 72 and Tirimula Tirupathi Devasthanam vs K M Krishnaiah (1998) 3 SCC 331.
45. Counsel for OP nos. 4 to 6 also relied on the following medical literature in support of their contentions:
(i) Neuropsychiatric Symptoms following metal-on-metal implant failure with cobalt and chromium toxicity - Research Article - Green et al, BMC Psychiatry (2017) 17-33;
(ii) Heavy Metal and Epigenetic Alternations in Brain Tumours, by Maria Caffo et al - Current Genomics, 2014, 15, 457-463;
(iii) ISHKS Joint Registry : A Preliminary Report - Jawahir A Pachore et al - Indian Journal of Orthopedics - September 2013 - Vol. 47 - Issue5;
(iv) Out of Joint - The Story of the ASR - Deborah Cohen BMJ 2011:342;
(v) Accelerating Failure Rate of the ASR total Hip replacement - D J Langton et al, Journal of Bone and Joint Surgery - Vol. 93 B No. 8, August 2011;
(vi) Five year results of the ASR XL Acetabular System and the ASR Hip Resurfacing System - An analysis from the Australian Orthopaedic Association National Joint Replacement Registry - Richard N de Steiger et al - J Bone Joine Surg Am. 2011:93:2287 -93;
(vii) Minimum 5 Year Follow=up of Articular Surface Replacement Acetabular Components used in Total Hip Arthroplasty - Udai S Sibia Am J Orthop.2018: 47 (6);
(viii) Clinical relevance of persistent postoperative pain after total hip replacement - a prospective observational cohort study - Joachim Erlenwein et al - Journal of Pain Research 2017: 10 2183 - 2193;
(ix) A review of the health hazards posed by cobalt-Dennis J Paustenbach et al - Review Articles - http://informahealthcare.com/txc;
(x) Cobalt toxicity in humans. A review of the potential sources and systemic health effects - Laura Leyseens et al - Unpublished Manuscript;
(xi) Interpreting cobalt blood concentrations in hip implant patients - Dennis J Paustenbach et al - Clinical Toxicology (2014) 52, 98 - 112;
(xii) Chromium as an Essential Nutrient for humans - Richard A Anderson - Regulatory Toxicology and Pharmacology 26,S35-S41 (1997) Article No. RT 971136;
(xiii) Depression and somatization influence the outcome of total hip replacement - Wolfgang Riediger et al - International Orthopaedics (SICOT) (2010) 34: 13- 18;
(xiv) Surgery-Induced Changes and Early Recovery of Hip - Muscle Strength, Leg Press Power, and Functional Performance after Fast - Track Total Hip Arthroplasty : A prospective Cohort Study - Bente Holm et al- PLOS One/ www.plopsone.org.
(xv) The Mechanism of Metallosis After Total Hip Arthroplasty - Chinedu C Ude et al - Regenerative Engineering Translational Medicine (2021) 7: 247 - 261:
The Counsel for the opposite party presented the findings of these studies in support of his contentions that while the implant was not inherently defective or flawed in its design, various factors peculiar to patients depending on their individual medical conditions and comorbidities impacted different individual/ patients differently and were a function of the anatomical specifications that were unique to individuals. It was contended that the product could not be stated to be defective because of these factors.
46. It was also submitted that the USFDA had warned patients in the USA with metal-on-metal (MoM) implants to be aware of potential symptoms after the surgery and was an indication that the device was not functioning properly. Common symptoms indicated included pain in the groin, swelling at or near the hip joint, a limp or change in walking ability. It was clearly indicated that there was no way to avoid production of metal particles in MoM implants which could cause "adverse local tissue reaction" (ALTR) or an "adverse reaction to metal debris" (ARMD) which may cause the implant to become loose or cause pain. It was also mentioned that increased levels of metal ions in the blood may cause, in some patients, other symptoms or illness including effects on the heart, nervous system and thyroid glands. On 24.08.2010 the OP had also conveyed reasons for revision as per data sets that were based upon previously reported data for ASR, including components loosening, component malignant, infection, fracture of the bone, dislocation, metal sensitivity and pain.
47. It was argued that in case of sale of defective goods, Section 14 (1) (d) of the Consumer Protection Act, 1986 provides for removal of the defect/replacement of defective goods. It was also contended that in the present case, the OP had already reimbursed expenses towards revision surgery and although no compensation could be awarded, OP had voluntarily paid Rs.25 lakh towards the revision surgery and therefore, no further relief could be granted. It was argued that in case of deficiency in service, the loss suffered by the complainant due to deficiency in service is required to be proven through documentary and oral evidence. Reliance was placed upon the judgment of the Hon'ble Supreme Court in GDA vs Balbir Singh (2004) 5 SCC 65 and HUDA vs R S Banga (2005) 9 SCC 460 and this Commission in Mrinmoy Dutta vs Dr Anupam Golash, 2016 SCC Online NCDRC 1524, Meenakshi Singh Tomara vs Dan Chogas Kitchen 2016 SCC Online NCDRC 90 and Preeti Sharma vs Yashoda Super Specialty Hospital, 2019 SCC Online NCDRC 1099.
48. However, the contentions of the opposite party are not liable to be accepted in the light of the judgment of the Hon'ble Supreme Court in Divisional Controller KSRTC vs Mahadeva Shetty, (2003) 7 SCC 197 which considered compensation to be awarded under the law of Torts when defective goods caused bodily injury for such injury also and held as under:
14. The main principles of law on compensation for injuries were worked out in the 19th century, where railway accidents were becoming common and all actions were tried by the jury. Though the cases have an antiquated air it is still useful to refer to them. The necessity that damages should be 'full' and 'adequate' was stressed by the Court by the Queen's Bench in Fair vs London and North Western Rly. Co. (1869) 21 LT 326. The word 'compensation' is derived from the Latin word 'compensare' meaning 'weigh together' or 'balance'. In Rushton vs National Coal Board (1953) 1 All ER 314 held that "Every member of this Court is anxious to do all he can to ensure that the damages are adequate for the injury suffered, so far as there can be compensation for an injury and to help the parties and others to arrive at a fair and just figure...."
15. It has to be kept in view that the Tribunal constituted under the Act as provided in Section 168 is required to make an award determining the amount of compensation which to it appears to be 'just'. It has to be borne in mind that compensation for loss of limbs or life can hardly be weighed in golden scales. Bodily injury is nothing but a deprivation which entitles the claimant to damages. The quantum of damages fixed should be in accordance with the injury. An injury may bring about many consequences like loss of earning capacity, loss of mental pleasure and many such consequential losses. A person becomes entitled to damages for mental and physical loss, his or her life may have been shortened or that he or she cannot enjoy life, which has been curtailed because of physical handicap. The normal expectation of life is impaired. But at the same time it has to be borne in mind that the compensation is not expected to be a windfall for the victim. Statutory provision clearly indicates that the compensation must be "just" and it cannot be a bonanza; not a source of profit but the same should not be a pittance. The courts and tribunals have a duty to weigh the various factors and quantify the amount of compensation, which should be just. What would be 'just' compensation is a vexed question. There can be no golden rule applicable to all cases for measuring the value of human life or a limb. Measure of damages cannot be arrived at by precise mathematical calculation. It would depend upon the particular facts and circumstances, and attending peculiar or special features, if any. Every method or mode adopted for assessing compensation has to be considered in the background of 'just' compensation which is the pivotal consideration. Though by use of the expression "which appears to it to be just", a wide discretion is vested in the Tribunal, the determination has to be rational, to be done by a judicious approach and not the outcome of whims, wild guesses and arbitrariness. The expression 'just' denotes equitability, fairness and reasonableness, and non-arbitrariness. If it is not so, it cannot be just. (See Helen C Rebello vs. Maharashtra SRTC AIR 1998 SC 3191.
16. This Court in R D Hattangadi vs Pest Control (India) (P) Ltd., (1995) SCC 551, laying the principles posited: (SCC p 556, para 9)
9. Broadly speaking while fixing an amount of compensation payable to a victim of an accident, the damages have to be assessed separately as pecuniary damages and special damages. Pecuniary damages are those which the victim has actually incurred and which are capable of being calculated in terms of money; whereas non-pecuniary damages are those which are incapable of being assessed by arithmetical calculations. In order to appreciate two concepts pecuniary damages may include expenses incurred by the claimant: (i) medical attendance; (ii) loss of earning of profit up to the date of trial; (iii) other material loss. So far as non-pecuniary damages are concerned, they may include (i) damages for mental and physical shock, pain and suffering, already suffered or likely to be suffered in future; (ii) damages to compensate for the loss of amenities of life which may include a variety of matters i.e., on account of injury the claimant may not be able to walk, run or sit; (iii) damages for the loss of expectation of life i.e., on account of injury the normal longevity of the person concerned is shortened; (iv) inconvenience, hardship, discomfort, disappointment, frustration and mental stress in life."
49. The contentions of the opposite party with regard to the Expert Committee and Arya Committee have been considered. The contention of the opposite party that the Expert Committee was neither a Drugs Technical Advisory Board (DTAB) nor Drugs Consultative Committee (DCC) nor a statutory committee of enquiry cannot be accepted. The Government of India appoints expert committees under the relevant Ministry or Department from time to time to examine and consider various issues of public importance. These committees are in addition to various statutory committees under the applicable Act and Rules thereunder. Such committees bring together experts to examine issues as per the mandate accorded to the committee by way of specific terms of reference. Its recommendations are considered by the Government and are subject to acceptance. The constitution of such committees, therefore, cannot be termed as either illegal or ultra vires unless the constitution of such a committee is established to be in contravention of any provision of law. The Aggarwal Committee and the Arya Committee were committees constituted by the Government in Ministry of Health and Family Welfare to deal with the important issue of faulty implants. Although they were non-statutory in nature, we do not accept the contention of the opposite party that their constitution was illegal or that the scope of technical review should have been considered by the DTAB. The High Court of Delhi vide its order dated 20.03.2003, while disposing the challenge to these Committees by the OPs, has held that the objections to the Committees would be considered on merits and that the pendency of the Writ Petition relating to the impugned reports will not preclude any other court to take a view depending upon the submissions made by the respective parties. In our consideration, the Committee comprised experts from the fields of orthopaedics and addressed issues of faulty implants manufactured by the OPs in the light of the global recall of the ASRTM Implant with a view to assess all pertinent issues relating to implants. The Committee reports set out reasons including the fact that the OP had been evasive in providing details and taken a note of the various difficulties encountered by patients who were implanted with the ASR XL Acetabular Hip System and DePuy ASR Hip Resurfacing System.
50. As per various judgments of the Hon'ble Supreme Court, including in Rajeev Suri vs Delhi Development Authority and Ors. (2022) 11 SCC 1, once an expert committee has duly applied his mind to an issue, the challenge to its decision has to be based on concrete material which reveals the total absence of application of mind. It was also held by the Hon'ble Supreme Court in Basavaiah (Dr) vs Dr H L Ramesh and Ors., (2010) 8 SCC 372 that "it is the settled legal position that courts have to show deference and consideration to the recommendation of any expert committee consisting of distinguished experts in the field."
51. In sum, therefore, while there is no doubt that the burden of proof to prove an inherent defect in the implant lies on the complainant, in the case on hand, the complainant has adduced reasonable evidence to prove that he was required to undergo a revision surgery for the left hip on 18.09.2012 to correct the THR surgery conducted on 26.11.2007 in respect of the ASRTM Implant in his left hip. It is evident that following the recall of the ASRTM Implant by the OP no. 5, the details of the recall were not shared with the complainant who learnt of such a recall during the course of a second opinion from another doctor. As it is admitted by the OP that the complainant was reimbursed the cost of the revision surgery, it is therefore, admitted that the THR surgery for the left hip conducted on 26.11.2007 was covered under the reasons for the recall of the ASRTM Implants by the OP. It is evident from the record that complaint was admitted in OP no.2 Hospital on 03.11.2007 with complaint of pain in both the hips for the past one year and was discharged on 05.11.2007. Surgery for THR in both the hips could not be undertaken on account of raised blood sugar levels and he was unfit for surgery at that time. Subsequently, on 26.11.207 THR bilateral was done using DePuy ASR Acetabular Implants. As per the record, the complainant consulted OP no.3 on 18.01.2008, 05.07.2008 and 15.11.2008 a (on which date X-ray of pelvic region of both the hips was also taken) followed by another X-ray on 02.03.2012. The contention of the OP that the complainant did not contact the OP nos. 2 and 3 with complaints of continuing pain cannot be sustained. It is also evident from the record that OP no.2 has not brought on record any evidence to indicate that the complainant suffered from bipolar disorder, as alleged by it, or that it had been under its treatment for the same.
52. The contentions of the OPs with regard to the findings of the Expert Committee and the Arya Committee have also been considered as per observations of the Delhi High Court. As discussed above, we consider it necessary to accept their recommendations in view of the inherent power of the Government of India to appoint an expert committee on issues of importance and to associate with such committees eminent experts to advise the Government.
53. As regards, the grant of just and fair compensation, the Hon'ble Supreme Court in Charan Singh vs Healing Touch Hospital (2000) 7 SCC 668 held that:
12. While quantifying damages, Consumer Forums are required to make an attempt to serve the ends of justice so that compensation is awarded, in an established case, which not only serves the purpose of recompensing the individual, but which also at the same time, aims to bring about a qualitative change in the attitude of the service provider. Indeed, calculation of damages depends on the facts and circumstances of each case. No hard and fast rule can be laid down for universal application. While awarding compensation, a Consumer Forum has to take into account all relevant factors and assess compensation on the basis of accepted legal principles, on moderation. It is for the consumer forum to grant compensation to the extent it finds it reasonable, fair and proper in the facts and circumstances of a given case according to the established judicial standards where the claimant is able to establish his charge.
13. It is not merely the alleged harm or mental pain, agony or physical discomfort, loss of salary and emoluments etc. suffered by the appellant which is in issue -- it is also the quality of conduct committed by the respondents upon which attention is required to be founded in a case of proven negligence.
14. It must be remembered that the National Consumer Forum has jurisdiction, without pecuniary limitations, to award proper compensation, even less than the one claimed in a given case, depending upon the established facts and circumstances of that particular case and the evidence led by the parties. The District Forum and the State Commission, on the other hand, have pecuniary jurisdictional limitations for granting compensation beyond their jurisdictional limits. ........."
15. .....A mathematical calculation based only on the amount of salary being drawn by the appellant could not be the sole factor to be taken into consideration to style the claim of the appellant "unrealistic" or "exaggerated" or "excessive". The appellant has virtually been condemned unheard after waiting for six long years. The legislative intent, for enacting the legislation, of a speedy summary trial, to settle the claim of the complainant (consumers) has been respected in its breach. The spirit of the benevolent legislation has been overlooked and its object frustrated by non-suiting the appellant in the manner in which it has been done by the National Consumer Forum. The Consumer Forums must take expeditious steps to deal with the complaints filed before them and not keep them pending for years. It would defeat the object of the Act, if summary trials are not disposed of expeditiously by the forums at the District, State or National levels.....
54. In Kavita v. Deepak, (2012) 8 SCC 604, it was held by the Hon'ble Supreme Court that-
"19. .....it is suffice to say that in determining the quantum of compensation payable to the victims of accident, who are disabled either permanently or temporarily, efforts should always be made to award adequate compensation not only for the physical injury and treatment, but also for the loss of earning and inability to lead a normal life and enjoy amenities, which would have been enjoyed but for the disability caused due to the accident. The amount awarded under the head of loss of earning capacity are distinct and do not overlap with the amount awarded for pain, suffering and loss of enjoyment of life or the amount awarded for medical expenses."
55. In Nand Kishore Prasad v. Mohib Hamidi, (2019) 6 SCC 512, it was held by the Hon'ble Supreme Court that-
"17. Thus, the compensation has to be calculated on the basis of twin criteria of age and income. But in the absence of income of the father or family, there is no legally acceptable norm available on record for the enhancement of compensation."
56. In Sarla Verma v. DTC, (2009) 6 SCC 121, the Hon'ble Supreme Court held that -
"17. .....While it may not be possible to have mathematical precision or identical awards in assessing compensation, same or similar facts should lead to awards in the same range. When the factors/inputs are the same, and the formula/legal principles are the same, consistency and uniformity, and not divergence and freakiness, should be the result of adjudication to arrive at just compensation."
57. In Balram Prasad v. Kunal Saha, (2014) 1 SCC 384, the Hon'ble Supreme Court held that-
"124. .......this Court is skeptical about using a straitjacket multiplier method for determining the quantum of compensation in medical negligence claims. On the contrary, this Court mentions various instances where the Court chose to deviate from the standard multiplier method to avoid overcompensation and also relied upon the quantum of multiplicand to choose the appropriate multiplier. Therefore, submission made in this regard by the claimant is well founded and based on sound logic and is reasonable as the National Commission or this Court requires to determine just, fair and reasonable compensation on the basis of the income that was being earned by the deceased at the time of her death and other related claims on account of death of the wife of the claimant...."
58. In the instant case, the claim of compensation by the complainant is not based upon any documentary evidence to indicate any permanent disability on account of the ASRTM Implant. The basis of claiming loss of income is based upon projections based on income tax returns which are not supported by evidence cannot be accepted as the basis for extrapolating the claim. No evidence regarding expenditure on medical attendance during the intervening period between the surgery and the revision surgery has also been brought on record. It is however, evident that a revision surgery was necessitated on account of continuing pain in the left hip although the hip transplant was done for both the hips. The complainant is therefore entitled for compensation for pain and suffering on account of having had to undergo a revision surgery apart from the pain in the intervening period. The opposite party has, apart from bearing the cost of revision surgery, compensated patients requiring revision surgery on this account. We are of the opinion that the complainant is entitled to be compensated similarly since he is placed in a similar situation as the other patients who underwent revision surgery.
59. The complainant has claimed Rs.1,58,79,385/- towards loss of income, mental agony, harassment, hardship suffered, pain endured, risk undergone and loss of status. However, the complainant has not produced reliable evidence to assess the loss of income, medical expenses etc., although it is not in dispute that he had to undergo revision surgery, albeit at the expense of OP no.5. We are also cognizant of the fact that the opposite party nos. 2 and 3 did not convey to the complainant the fact that the ASRTM Implant had been recalled and that under certain circumstances revision surgery was advised. Therefore, we think it proper that apart from the compensation offered by the OP, the complainant is entitled to Rs.10 lakh for pain and suffering. OP no.5 is in any case providing Rs.25 lakh to a patient who undergoes revision surgery and also is reimbursing the expenses of revision surgery.
60. As far as the quantum of compensation claimed by the complainant is concerned, we do not find the submissions of the complainant suitably buttressed by evidence to establish his claim based on loss of employment and earnings to be directly attributable to the surgery and ASRTM Implant. Contentions in this regard have not been accepted by us. However, keeping in view that the ASRTM Implants had been recalled from the country on 2010 and the complainant was found eligible for a revision surgery by the OP, he is entitled to compensation on par with other similarly placed persons. In Consumer Complaint no.162 of 2014 this Commission on 03/09/2024 has held that all such patients in India who used ASR XL implant manufactured and imported by the OP and who have undergone revision surgeries prematurely, are entitled to a certain minima or basic level of compensation from the OP, irrespective of the nature and extent of complication which such implants caused in each individual case. Where complainants are able to establish specific serious adverse effects of such implants due to increased level of cobalt and/or chromium and/or other symptoms or complications, they are entitled to additional compensation. The quantum of such additional compensation would obviously vary from case-to-case depending on the facts and circumstances of each case and the nature and seriousness of the adverse effect as established by the complainant based upon evidence on record.
61. In the instant case the complainant has not brought on record any degree of physical disability as a consequence of the implant in his left hip. He is not, therefore, entitled to compensation as per the formula devised by the Arya Committee with regard to the compensation for non-pecuniary damages. The opposite parties, while challenging the Expert Committee and Arya Committee reports before the Delhi High Court, have already expressed willingness to pay Rs 25,00,000/- to all patients who had undergone revision surgery subject to verification of each case. We hold the complainant to be eligible to a similar compensation, along with compensation for pain and trauma.
62. We do not find any liability on the part of OP no.1 who has been incorrectly impleaded since there was no connection between the complainant and OP no.1. We also do not find any liability on part of OP no.2 and 3 insofar as the complainant's allegation regarding the THR surgery on 26.11.2007 being wrongly done is concerned. As regards the allegation that OP nos. 2 and 3 did not intimate the complainant about the recall of the ASM Implants is concerned, the complainant has not brought on record any record to show that it had approached them after the recall noticed was issued by OP no.5 to substantiate the allegation of not having acted on any request of the complainant.
63. In view of the aforesaid discussions and in the facts and circumstances of the case, the complaint is partly allowed. Opposite parties 4 to 6 are jointly and severally directed to pay Rs.35 lakh as compensation with interest @ 6% per annum from the date of filing of this complaint till the date of payment to the complainant, within 2 months from the date of this judgment. It shall be open to the opposite parties to adjust Rs.25 lakh to this amount if the same stands paid. Opposite parties shall also jointly and severally pay the complainant a sum of Rs.1.00 lakh towards cost.
64. The complaint is disposed of in terms of the above directions. Pending IAs, if any, also stand disposed by this order.
..................................................J RAM SURAT RAM MAURYA PRESIDING MEMBER ...................................... SUBHASH CHANDRA MEMBER ................................................ DR. INDER JIT SINGH MEMBER