Usha Gupta vs M/S. Johnson & Johnson Limited & 7 Ors. on 3 September, 2024

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National Consumer Disputes Redressal

Usha Gupta vs M/S. Johnson & Johnson Limited & 7 Ors. on 3 September, 2024

NATIONAL CONSUMER DISPUTES REDRESSAL COMMISSION NEW DELHI CONSUMER CASE NO. 302 OF 2015 1. USHA GUPTA Resident of B-49, Sector - 20, NOIDA ...........Complainant(s) Versus 1. M/S. JOHNSON & JOHNSON LIMITED & 7 ORS. Managing Director, Registered Office at A-1/50, Room No .2, 100 Shed Area, GIDC Vapri, Tal Pardi (Vaisad), GUJARAT, 2. M/S. DEPUY ORTHOPAEDICS INC., Registered Office at St. Anthony's Road, Leeds, LS118Dt, UNITED KINGDOM. 3. DUPUY MEDICAL PRIVATE LIMITED Through Its managing Director, Registered Office at 30, Forjett Street, MUMBAI - 400 036. 4. MAX SUPER SPECIALITY HOSPITAL, Through its Managing Director, 1, Press Enclave Road, Saket, NEW DELHI -110017. 5. DR. S.K.S. MARYA, Director Orthopedics and Joint Replacement, Max Healthcare, Max Super Speciality Hospital, 1, Press Enclave Road, Saket, NEW DELHI - 110 017. 6. DR. CHANANDEEP SINGH, ORTHOPEDICS CONSULTANT MAX SUPER SPECIALITY HOSPITAL,1, PRESS ENCLAVE ROAD, SAKET, NEW DELHI-110017 7. DR. SUMEET RASTOGI, ORTHOPEDICS CONSULTANT MAX SUPER SPECIALITY HOSPITAL, 1, PRESS ENCLAVE ROAD, SAKET, NEW DELHI-110017 8. DRUGS CONTROLLER GENERAL (INDIA) Director General Of Health Services, Ministry of Health and Family Welfare, UNION OF INDIA. ...........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 : FOR THE COMPLAINANT : MR. DIVYANSHU SAHAY, ADVOCATE
MS. SHRADHA NARAYAN, ADVOCATE FOR THE OPP. PARTY : FOR THE OPP. PARTY : MR. SUKUMAR PATTJOSHI, SENIOR ADVOCATE
(JOHNSON & JOHNSON) MR. RAHUL RAY, ADVOCATE
MR. PARAS CHOUDHARY, ADVOCATE
MR. SARTHAK GARG, ADVOCATE
MR. RAM KRISHNAN RAO, ADVOCATE
FOR THE OPS 5 & 6 : NEMO
FOR OPPOSITE PARTY-4 : MR. YUVRAJ SINGH, ADVOCATE
: MR. ADITYA AWASTHI, ADVOCATE
FOR OPPOSITE PARTY-8 : MR. KIRTIMAN SINGH, ADVOCATE
: MR. VARUN RAJAWAT, ADVOCATE
Dated : 03 September 2024 ORDER

(PER MR. JUSTICE RAM SURAT RAM (MAURYA), PRESIDING MEMBER)

1. Heard Mr. Divyanshu Sahay, Advocate, for the complainant, Mr. Sukumar Pattjoshi, Senior Advocate, assisted by Mr. Rahul Ray, Advocate, for OP-1 to 3, Mr. Yuvraj Singh, Advocate, for OP-4 and Mr. Kirtiman Singh, Advocate, for OP-8.

2. Usha Gupta (the complainant) has filed above complaint for directing the OPs jointly or severally to pay (i) Rs.588000/- towards costs of medical attendance; (ii) Rs.15000000/- as compensation for physical shock, agony, pain and suffering; (iii) Rs.2500000/- as compensation for causing perpetual disability; (iv) Rs.5000000/- as compensation for internal bodily injury, which is neither identifiable nor curable; (v) Rs.2500000/- as compensation for loss of expectation of life due to medical complication such as metal poisoning, damage to central nervous system, risk of cancer, osteolysis etc.; (vi) Rs.10000000/- as compensation for inconvenience, hardship, discomfort, frustration, disappointment, emotional distress and mental stress; (vii) pendent lite and future interest on above amounts @18% per annum; (viii) litigation costs; and (ix) any other relief which is deemed fit and proper in the fact and circumstances of the case.

3. The complainant stated that Johnson & Johnson Limited, DePuy Orthopaedics Inc and DePuy Medical Private Limited (OPs-1, 2 and 3) were the companies, registered under the Companies Act, 1956 and group of companies of Johnson & Johnson, U.S.A., which was a leader in global orthopaedic industry. DePuy Orthopaedics Inc (OP-2) designed, fabricated, manufactured and marketed Acetabular System Resurfacing (ASR XL) and claimed its life for 15-20 years. Drug Controller General of India (OP-8) granted licence to DePuy Medical Private Limited (OP-3) for import in India and sell of ASR XL device, on 29.11.2006 under Rule-27-A of the Drug and Cosmetic Rules, 1945, without conducting clinical test and determining its safety. The complainant was suffering with pain in her right thigh for about seven years and consulted with Dr. S.K.S. Marya, Dr. Chandandeep Singh and Dr. Sumeet Rastogi (OPs-5 to 7) at Max Super Speciality Hospital (OP-4) (for short the hospital) on 31.03.2009, who after examination, advised for total hip replacement (for short, THR) surgery and convinced for ASR XL hip implant. OPs-4 and 5 claimed to be pioneer and first hospital in Asia, who had officially launched ASR XL hip implant and successfully implanted in the hip of the patient. OP-5 admitted the complainant in the hospital on 31.03.2009 and performed total hip replacement surgery and implanted the ASR XL hip on 02.04.2009. Although the complainant had severe pain and limping but she was discharged from the hospital on 07.04.2009. The complainant took medicines and followed post-surgical instructions but was not relieved from pain. The complainant visited OPs-5 to 7 in the hospital on 17.04.2009, 15.05.2009, 15.06.2009, 18.07.2009 and 14.10.2009 for review. Due to pain and complications, OPs-5 to 7 took X-ray of the hip at many times but could not find out the real cause for the pain. Due to serious discomfort, the complainant again visited the hospital on 29.11.2010. Then OP-5 asked her to register on the helpline of OPs-1 to 3 for blood test for cobalt & chromium and MRI. X-ray and MRI of right hip and lateral and blood test report of the complainant revealed (i) Reduced bone density with preserved texture; (ii) Residual osteoarthritis changes with geode formation, where regression in size noted as compared to old X-ray. Reduction in bone thickness noted of acetabular roof centrally; (iii) Severe atrophy of the right piriformis indicating severe pain in buttock; (iv) Moderate atrophy of the gluteus minimus, medius and maximus indicating degeneration of hip muscles; (v) Fragments of bone debris; (vi) Alarming low level chromium <0.5 ug/l as against normal level of 0.70 - 28.00. Due to persistent progressive pain, limp while walking, limitations of movements and difficulties in day to day activities, the complainant consulted with various orthopaedic doctors for persistent pain, namely Prof (Dr.) Suraj Bhan on 29.11.2013 (previously also on 06.09.2011), Dr. Anil Saxena at Gwalior on 17.01.2014, Dr. Somnath Bani at Bombay on 03.02.2014, Dr. Surendra Nath at Hyderabad on 03.03.2014, Dr. Gaurav Bhardwaj on 26.05.2014 and 30.07.2014, who advised for revision surgery and pain killers. Radiological reports conducted on the advice of above doctors gave findings that (i) severe muscle atrophy of the right piriformis with moderate atrophy of gluteus minimus, medius and maximus; (ii) Hetrophic ossification/ calcification along the superiolateral aspect of the joint; (iii) Definite hint of protrusion in right acetabular space; and (iv) Degenerative changes noted in the right hip joint in the form subchondral cyst formation, sclerosis. The complainant got registered with OPs-1 to 3 in November, 2013, who obtained blood test report, X-ray and MRI from their consultant in Mumbai but did not advice for any medicine. Drug Controller General of India found that (i) The patients suffering from the ASR XL device required revision surgery within first five years; (ii) Post surgery, some patients are represented with variety of symptoms including pain, swelling and difficulties in walking; (iii) The patient may also develop progressive soft tissue reactions due to the metal debris generated as the metal components wear out over time; and (iv) If left untreated, the condition may cause pain and swelling around the joint and could damage muscles, bones and nerves around the hip. OP-8 issued alert on 09.12.2013 and directed for recall of ASR XL hip implants due to increased rate of revision and directed inter alia orthopaedic surgeons not to implant DePuy ASR XL hip implants; (ii) Return of all unused ASR XL hip implants to the manufacturer; (iii) Inform all patients implanted with ASR XL hip implants about this recall and schedule them for a follow-up visit; (iv) Follow-up all patients implanted with the ASR XL hip implants with clinical examination at least annually; and (v) So far as patient with symptoms of abnormal pain, limping, swelling around the hip, deteriorating hip function or radiological abnormality, various remedies have been suggested. Although OPs-1 to 3 were under legal and moral obligation to take reasonable step to prevent damage, harm and injury to the patients but they neglected above direction of the Regulator. OPs-4 to 7 also owe a duty of care to their patients and the medical ethics require to exercise extreme care and diligence while treating the patients but they treated the complainant in utterly unprofessional, unethical and against the provision of law and did not take reasonable care in her treatment although they claim to be super specialist. Despite knowing the possibility of side effect of ASR XL hip implant, they implanted it without informing about its side effects. OPs-1 to 7 still not able to find out root cause of her discomfort and prescribed useless drugs although her condition is worsening day by day. Even after recall of ASR hip implant by OPs-1 to 3, they did not inform the complainant in this respect. The complainant has regular pain even in sit and sleep. She is unable to walk, climb up and come down on the stair without aid and assistance of some one. She needs an attendant regularly. Due to side effect of ASR XL hip implant, soft tissue surrounding the joint of the complainant stands destroyed and she is left with perpetual long term disability. In March, 2010 OPs-1 to 3 also acknowledged that there was more than high-rate failure in the ASR XL hip implant and approximately 12% patients were requiring revision surgery. Even thousands of lawsuits were filed all over the world against the opposite party. Data from study revealed approximately 13% failure of ASR XL hip, which was dangerous. It was found that due to failure of the ASR XL hip device can cause increased metal ion levels in the blood, bone staining, necrosis, swelling, nerve damage, tissue damage and muscle damage. OP-2 voluntarily recalled the ASR XL hip device on 24.08.2010, worldwide. ASR XL hip implant was a metal-on-metal device, where acetabular and femoral component both were made of metal. Design of ASR XL hip implant has a shallow ASR cup to facilitate less coverage of the femoral ball within the socket, which in turn allows greater motion of the hip joint after replacement surgery. When the leg is fully flexed or extended or brought out to the side, the leg motion is ultimately limited as the neck hits the edge of the cup rim. There is no sufficient coverage to fully distribute the forces of the ball against the cup without over concentrating those forces- usually at the edge of the cup. Due to greater concentration of forces over limited area of contact between the ball and the socket, there is greater wear in general and wear over the edge or periphery of the cup/ball contact in particular. The cups used in women are generally smaller, which have more shallow. Failure rate is high in smaller cup as published by Australian Hip Registry. The larger femoral heads show corrosion effect and metal wear. Theory of OPs-1 to 3 that the tighter the fit, the less room, there is for imperfect motion. The more perfectly matched the surfaces and the narrower the space between them the less wear there would be. Theory in designing the ASR XL was to create a ball-in-cup clearance that was the lowest in the industry. Investigations state that the problems with this design include but not limited to:- (i) As designed, any deformation of the cup when it is implanted will cause clamping or complete loss of any space and direct metal-on-metal wear. The cup tends to deform when hammered into the bone during the hip replacement surgery; (ii) By designing the cup for a clearance of only 100 micrometres in a shallow cup with low coverage increased wears at the periphery of the cup is seen. This peripheral wear seems predicable in light of the alpha angle analysis and in light of the cup positioning anticipated at surgery. Alpha angle analysis shows that in cup that are less than 55 degrees the coverage starts to get very small indeed; (iii) If the cup is in exact position of 45 degrees in a wear testing simulator, there might be low wear- but few surgeons can place te cup exactly in 45 degrees and with increased tilt the wear of the ASR cup increases markedly. This is specially so given the very narrow clearance; (iv) The design of the ASR cup to be placed in 45 degrees of vertical tilt (also known as abduction) is such that even very trained orthopaedic surgeons are not able to properly (according to DePuy) insert because of various factors. Firstly, I the operating room, surgeon seeks to obtain this angle by aligning the cup into the bone with the instruments provided by OP-1 to 3 for the ASR. Since the surgeon look into the patient's own acetabulum, he uses his own eyes to align the cup in the desired position, which in effect results in failure of the ASR device by malposition. Second the mono-block design of the ASR cup is another hindrance, i.e. it being on one piece and modular, the surgeon cannot put the shell first and then a modular insert. Thus, surgeon does not get as good look at the position of the cup into the patient's bone as the cup goes into place. Such inherent defect in design of the ASR XL put greater risk of dislocation of joint. Dislocation necessitates patients to undergo revision surgery. Defective designed ASR XL implants result in number of health issues. Neither OPs-1 to 3 nor OPs-4 to 7 ever informed about the complications and side effects of ASR hip implant before surgery. Then above complaint was filed on 24.04.2015.

4. M/s. Johnson & Johnson (OP-1) filed its written statement on 21.07.2015 and stated that DePuy Medical Private Limited was subsidiary of DePuy Orthopaedics Inc, USA. DePuy group of companies were founded in 1895 and were the world's oldest manufacturer of orthopaedic products and with a portfolio of over 200 products, it was leader in global orthopaedic industry. OP-1 was engaged in business of importing and marketing orthopaedic implants in India. The ASR XL hip was manufactured by DePuy International Limited, UK. The ASR XL hip is a ball-and-socket joint. Ball portion is called femoral head and socket portion is called acetabulum. The bones of femoral head and acetabulum of the pelvis are separated by spongy material (cartilage) and by a sac of fluid (synovial fluid), both of which serve to lubricate the joint. A properly functioning hip joint is critical for normal everyday activities such as walking, running and climbing. Given the very design of the natural hip joint, the femoral head moves within against the acetabulum with every movement, which causes natural wear and tear of the hip joint. The cartilage or the bones may deteriorate for various reasons leading to stiffness, pain, difficulty in walking etc., which may warrant a hip replacement. Hip implants are made of various materials like metal-on-metal, metal-on-ceramic, ceramic-on-ceramic and metal-on-polyethylene. All artificial hips require one component to slide against another component and it is inevitable that materials at the surface will have some wear as they interact. One of the most important factors in any hip replacement is the rate of wear because process of wear leads to production of debris. In some patients, this debris may set up a reaction locally in the joint that leads to the aseptic loosening of the prosthesis. Implant wear is expected and seen in all types of implants irrespective of the material they are made of. All prostheses have a finite life span and they wear over a time period. Various types of implants have their own risks and benefits, which the surgeons consider with their patients when discussing an appropriate prosthesis. A metal-on-poly implant wears out faster than a metal-on-metal one. Metal-on-metal implant also allows the use of large size femoral heads. The larger the ball there is less risk of subsequent dislocation. While the wear in either case is higher than found in ceramic-on-ceramic implants. Ceramics are more scratch resistant and smoother than any of these other implant materials but are likely to break in the body. All orthopaedic implants experience wear over time and generate what is called wear debris, irrespective of the material used in it. European Union granted 'CE marking' to the ASR XL hip, which is a declaration that the product complied with the essential requirements of the relevant European health, safety and environmental protection legislation. The ASR XL hip was launched in USA in 2005 for which United States Food and Drug Administration granted "Standard and Certification of Product". Drug Controller General of India granted licence to OP-3 on 15.12.2006 for import of the ASR XL hip, which was renewed on 18.02.2010 and was valid till 31.10.2012. The guidance given by USA FDA on metal-on-metal hip implants as stated on the US FDA Website is as under:- "All artificial hip replacement system have risks related to implant or material wear. All artificial hips require one component to slide against another component and it is inevitable that material at the surfaces will wear as they interact. Because the metal ball and the metal cup slide against each other during walking or running, some tiny metal particles may wear off of the device and enter into the space around the implant. It is known that every different type of hip implant system has its own set of risks as well as its own set of benefits. MoM hip implants overall have been shown to provide significant benefits (e.g. high survivorship) in certain patient populations. Although the exact prevalence of adverse reactions to metal debris is not known, current experience leads us to consider the adverse outcomes to be relatively low or equal to other types of hip implants. Thus for many patients, currently available information supports a favourable risk-benefit ratio". UK National Institute For Clinical Excellence issued a guidance document entitled "Guidance on the Selection of Prostheses for Primary Total Hip Replacement" which states the following about expected revision rates "1.1 Using the most recent available evidence of clinical effectiveness, the best prostheses (using long term viability as the determinant) demonstrate a revision rate (the rate at which they need to be replaced) of 10% or less at 10 years. This should be regarded as the current 'benchmark' in selection of prostheses for Primary Total Hip Replacement. In the case of total hip replacement surgery, the process involves removal of the deceased femur head and its replacement with a prosthetic ball made of metal or ceramic. The acetabulum of the hip joint is prepared to receive a prosthetic cup. A stem is also placed in the femur to support the femoral head. A prosthetic device is an artificial device extension that replaces a missing body part. Hip replacement surgery becomes necessary in the case of arthritis of age (osteoarthritis), gout, inflammatory diseases, avascular necrosis (alcoholic or potential immunological problems that result in cutting of blood supply to the head of the femur) etc. It may also require where the patient has suffered trauma or injury directly on hip joint causing misalignment and/or destruction of the articulating surfaces (head of femur & socket). Depending upon the clinic-radiological assessment and imaging and other factors, the surgeon decides on as to whether to do a resurfacing or a total hip replacement and the type of implant that needs to be used. Based on the decision of the surgeon, the patient and family are counselled by the medical team on the risk-benefit ratio and a joint decision is taken by the surgeon, the patient and his family members. OP-1 collects the data about performance of its products from various sources like joint replacement registers, published literature, company sponsored clinical trials, internal complaints data and unpublished clinical research reports in respect of all its products. The data is collected for the purpose of its continuous evaluation, information to the surgeons, other healthcare professionals, governments, orthopaedic companies and the community. In February, 2010, the data from Australian Orthopaedic Association National Joint Replacement Registry indicated higher than expected revision rate for some of the components namely the ASR acetabular cup and unipolar femoral head used with DePuy stems in total hip replacement. The data suggested that the revision rate may be higher (i) where a large proportion is female or has small acetabula; and (ii) smaller heads (less than 50 mm diameter) are associated with a higher rate of revision up to 8-9% at three years. DePuy U.K. believed that the overall revision rate for ASR XL (i.e. other systems) continued to be in line with the class of metal-on-metal mono-block system as a whole. Therefore, an urgent safety notice dated 05.03.2010 was issued informing the surgeons that due to higher rate of revision, they should implant the product as per the instructions mentioned in the "Instructions for Use", which was part of the product pack. In the notice, certain action points were also informed to be followed by the surgeons. OP-1, vide letter dated 08.03.2010, also sent this notice/ instruction to the Drug Controller General of India (DCGI). In August, 2010, OP-1 received another unpublished data from National Registry of England & Wales showing that 5 years revision rate of ASRTM Hip Resurfacing System was 12% approximately and for ASRTM XL Acetabular System was 13% approximately. Risk for revision was highest with ASR XL head sizes below 50 mm in diameter and among female patients. After receiving this data, OP-1 voluntarily recalled the product from all over the world vide recall notice dated 24.08.2010, specifically stating that due to the new NJR data showing higher than expected revision rate at five years, DePuy was issuing a voluntary recall of all ASR XL products. Thereafter, OPs-1 to 3 did not sell ASR XL products to any dealer or the hospital. OP-1 also took remedial step i.e. "Reimbursement Process and Documentation", engaging Puri Crawford & Associates India Private Limited as a Claim Management Organization to handle all the claims related to the recall. In this regard, OP-1 set up a toll free number and a website in English and Hindi to call and register themself. OP-1 issued recall notices to 337 surgeons across India, vide letter dated 26.08.2010. The communication dossier consisted of the format of letters that the surgeons were required to give to their patients. List of documents were (a) Healthcare Professional Letter; (b) International Hospital Letter; (c) Patient Letter; (d) Surgeon to Patient Letter; (e) ASR Information for Patient; (f) ASR Codes list; and (f) Patient consent form. One of the action points was testing of blood for the levels of cobalt and chromium, if the surgeon was concerned for the hip replacement. Relevant portion was as under:- "(i) For patients who are symptomatic or implanted with a cup angle greater than 45⁰, particularly where a small component has been implanted. (ii) Consider measuring cobalt and chromium ion levels in whole blood and/or performing cross sectional imaging including MRI or ultrasound scan. (iii) If metal ion levels in whole blood are elevated above 7 parts per billion (ppb) for either metal ion, a second test should be performed three months after the first in order to identify patients who require closer surveillance, which may include cross sectional imaging. (iv) If MRI or ultrasound scan reveals soft tissue reactions, fluid collections or tissue masses, then revision surgery should be considered. Second time, OP-1 issued "Reimbursement Process and Documentation" to 327 surgeons across India, in March, 2011 and third time to 342 surgeons across India on 01.11.2011. Total 930 patients were registered under the above scheme, out of which 190 underwent revision surgery. Many patients having ASR XL devices did not require revision surgery as their implants were functioning well. The patients, who underwent revision surgery, had multi-fold symptoms and revision cannot be attributed to the ASR XL device alone. Dr. S.K.S. Marya performed the surgery of total hip replacement of the complainant and used metal-on-metal hip implant. The surgeon used to decide suitability of the implant after undertaking requisite tests and observing precautionary measure. The patient and her family members were told about the risk and benefit of the surgery and thereafter they took decision for surgery and use of ASR hip. The complainant admits that Dr. S.K.S. Marya informed her about remedial step i.e. "Reimbursement Process and Documentation", and asked her to get her register with ASR helpline in November, 2010. She did not produce any evidence to prove that her ASR hip implant suffer from any defect. Many metal-on-metal hip implants are made of cobalt-chromium alloy. The implant has ball and socket components that move against each other. The components are made of metal and wears over time and generates very small particles, which is an expected process. Different bodies respond to the particles in different ways. US FDA guidance on metal-on-metal hips and chromium-cobalt says that these particles do not cause problem for most of the patients, but a small number of patients may have an adverse reaction to them. Common symptoms are pain in groin, hip or leg, swelling at or near the hip joint and limp or change in walking ability. These being the common symptoms, the allegations made by the complainant do not prove that she suffered any problem due to a defective implant, although revision rate of surgery was found to be higher than the normal rate. The ASR device was recalled due to high rate of revision surgery. Recall of the ASR XL device did not mean that the device was defective. These implants were supplied in the market after extensive studies and research and used all over the world for the decades. The OP has not concealed the fact that in August, 2010, rather the OP voluntarily issued recall notice and the said notice was sent to numerous surgeons and clinicians, who informed the same to the patients. The recall notice was also sent to DCGI. Thus, there was no question of concealing the fact relating to recall notice. The complainant has not substantiated the allegation by filing any evidence to show that FDA had received several complaints regarding defect in the device.

THR surgery of the complainant was done and ASR XL hip was implanted on 02.04.2009. ASR XL hip was recalled on 24.08.2010 and the complainant was informed about the remedial step of OP-1 in November, 2010. She got registered on helpline of OP-1 in November, 2013. Then her blood test, X-ray and MRI were conducted. Her cobalt and chromium level was within normal range and nothing abnormal was found in her X-ray and MRI. The complainant did not produce any record or report to show that MoM implant had corroded resulting in any issue to her. The complaint was filed on 24.04.2015, which is highly time barred. The cause of action for filing the complaint is not continuing and the complaint is time barred. The dispute raised by the complainant is not a consumer dispute. The complainant has neither substantiated the allegation of misrepresentation, inducement and concealment nor given any basis for exaggerated compensation, claimed in the complaint.

5. Max Super Speciality Hospital and Dr. S.K.S. Marya (OPs-4 and 5) filed their joint written version and medical papers of the complainant. OPs-4 and 5 stated that the hospital is an unit of Max Healthcare Institute Limited and registered with the Directorate of Health Services, Government of NCT of Delhi, vide Registration Certificate No.716 dated 01.05.2006. The hospital is fully equipped with the latest technologically advanced medical gadgets, including fully equipped critical care facilities backed by state of art medical equipment. All the doctors and other staffs employed in the hospital are highly qualified and competent to take care of the patient and their management. Dr. S.K.S. Marya did MBBS in 1981 and was awarded "Best Graduate", MS (Ortho) from PGI Chandigarh and was awarded "Best Post Graduate", DNB (Ortho) in 1985 from National Board of Exams and MCh (Ortho) in 1991 from University of Liverpool, U.K. He was awarded FRCS England. He had numerous publications and presentations to his credit including several papers in international journals. He did several workshops and courses and is members of various Orthopaedic Association. He introduced several new surgical techniques. Previously he was Director, Division of Joint Replacement Surgery and Consultant Orthopaedics at Indraprastha Apollo Hospital, Delhi. In the year 2009, he was Chairman & Chief Surgeon of Orthopaedics and Institute of Joint Replacement Surgery, in the hospital. Usha Gupta, aged about 52 years visited the hospital on 21.03.2009 in the hospital as an 'Out Patient' with a history of pain in her right hip for the last 7 years and past surgical history of caesarean, 37 years back. Pain relieved by taking analgesic. Pain gradually increased in severity, limping. She was examined by the team of OP-5 to 7 and her right lower limb shortening 1 cm was found. Due to pain in her right hip for the last 7 years and shortening of lower limb, she was advised for total hip replacement. DePuy ASR XL hip was approved by United States Food and Drug Administration, Drug Controller General of India and held CE certification, which substantiates that it complied with the requirements of relevant European health, safety and environmental protection legislation. She was explained risk and benefits of ASR XL hip, manufactured by OP-1 to 3, who were a well-known brand of manufacturing ASR hip and about entire procedure for ASR hip surgery. After consulting with her family members and others, she agreed for total hip replacement of ASR XL hip and was admitted in the hospital on 31.03.2009 for hip replacement and her surgery was done on 02.04.2009. The team of OP-5 to 7 took pre-operation and post-operation care and conducted frequent checks to ascertain her wellbeing. After her condition being stable, she was discharged from the hospital on 07.04.2009 with instruction for follow up visit on 17.04.2009 for removal of stitches and on 15.05.2009 for X-ray and review. She came on 15.05.2009 and 18.07.2009. Her X-ray showed implant in situ with no lysis along the prosthesis. She did not complain severe pain and discomfort. All the medical papers were handed over to her, which were concealed. When OP-1 took remedial step for "Reimbursement Process and Documentation", then she was informed on 29.11.2010 and was asked to get registered on the helpline of OP-1. However, she got herself registered on 04.12.2013. It has been denied that she had suffered from any injury due to ASR XL hip implant. During her treatment, the team of the doctors and the hospital staff had taken due care and caution. They had no knowledge about her consultation with other doctors. The complaint was filed on 24.04.2015, which is highly time barred.

6. Dr. Chandeep Singh and Dr. Sumeet Rastogi (OP-6 and 7) filed their joint written reply on 15.11.2016, in which, similar plea as taken by OP-4 and 5 were taken. Drug Controller General of India (OP-8) filed its written version and stated that for manufacture, import, distribution and sale a licence is required to be obtained under the provisions of Drug and Cosmetics Act, 1940 and Drug and Cosmetics Rules, 1945 from the Licencing Authority. In case of import, after registration of the manufacturing site and device by the Licencing Authority, Import Licence is issued. Licencing Authority granted Registration Certificate and Import Licence to DePuy Medical Private Limited (OP-3) for import and sell in India of ASR XL device, manufactured by M/s. DePuy International Limited, U.K. on 29.11.2006, which was valid till 31.10.20109 and renewed till 31.10.2012. DePuy International Limited voluntarily recalled ASR XL implant globally on 24.08.2010. Upon issuance of show cause notice, OP-1 to 3 surrendered Registration Certificate and Import Licence, which were cancelled in the year 2012. CDSCO issued "medical device alert" on 09.12.2013. Ministry of Health and Family Welfare, Government of India constituted an Expert Committee on 08.02.2017, to examine suitability of the ASR XL hip implant. Report of the expert committee is awaited. Suitable steps for compensation will be taken after obtaining expert committee report.

7. The complainant filed Rejoinder replies, to above written versions, Affidavit of Evidence of Usha Gupta, Additional Affidavit of Evidence of Usha Gupta and documentary evidence. OP-1 filed Affidavit of Evidence of Ameya Joshi. OP-4 filed Affidavit of Evidence of Dr. Nalini Kaul. OP-5 filed Affidavit of Evidence of Dr. S.K.S. Marya. OP-6 filed Affidavit of Dr. Chandeep Singh. The parties have filed the written arguments.

8. The complainant produced a Report dated 19.02.2018 of an Expert Committee constituted by Ministry of Health and Family Welfare, Government of India, along with Rejoinder.

Ministry of Health and Family Welfare, Government of India, vide order dated 08.02.2017 constituted a High Powered Expert Committee under the Chairmanship of Dr. Arun Kumar Aggarwal, Ex-Dean and Professor of ENT, Maulana Azad Medical College, New Delhi to examine the various issues pertaining to the faulty ASR Hip implants ("Expert Committee"), who submitted its report dated 19.02.2018. The Terms of Reference (ToR) and report of the Committee were as follows:-

i. To assess all pertinent issues relating to Faulty ASR Hip Implants manufactured by M/s DePuy International Limited, U.K.

ii. To review actions taken by the firm to replace Faulty ASR Implants and adjudge adequacy thereof,

iii. To review the Medical Management and compensation provided by the firm to victims of Faulty ASR Implants,

iv. To review all Adverse Event reports of Faulty ASR Implants and Corrective and Preventive Action (CAPA) taken by the firm,

v. To make specific recommendations to the Government on further course of action in the matter in the light of the entirety of facts.

vi. To assess the regulatory action taken by NRAs from ICH countries on faulty ASR Hip Implant.

( a) The Committee comprised of following :-

Ii)

Dr. Arun Agarwal, Professor of ENT, MAMC New Delhi

Chairman

(ii)

Dr.Rajesh Malhotra, Professor & Head, Department of Orthopedics, AllMS, New Delhi

Member

(iii)

Dr.YK Gupta, Head Department of Pharmacology, AIIMS, New Delhi

Member

(iv)

Dr. R. K. Arya, Professor and HOD, Department of Orthopaedics, RML Hospital, New Delhi

Member

(v)

Dr. V. K. Sharma, Ex-Director, Central Institute of Orthopaedics, VMMC & Safdarjung Hospital, New Delhi

Member

(vi)

Dr.Sudhir Kumar, Prof and Head of Department of Orthopaedics, GTB Hospital, New Delhi

Member

(vii)

Dr. C. Nath, Chief Scientist, Division of Texicology, CDRI, Lucknow

Member

(viii)

Mr. Begon Mishra, Founder Trustee JagoGrahakJago, Consumer Online Foundation

Member

(ix)

Mr. D. N. Sahoo, Deputy Secretary Ministry of Health Land Family Welfare, New Delhi

Member

(x)

Dr BT Kaul, Professor of Law, Delhi University, Delhi Law Centre-II, DhaulaKuan, New Delhi-110 021

Member

(XI)

Dr. S. Eswara Reddy, Joint Drugs Controller ( I), CDSCO

Member Secretary

(b) The Committee had series of meetings, interactions with relevant parties and consultations with National Regulatory Authorities of USA, UK, Japan, EU, Australia and Brazil. The Committee, after considering various information / documents / literature from various sources including patients, orthopedic surgeons, the manufacturer / importer / supplier of implants, hospitals, court orders and CDSCO submitted its report to the Government of India, Ministry of Health and Family Welfare on 19.02.2018. The said report / recommendations were accepted by Government of India. Some of the observations / findings of the Committee, relevant for the present case, are given below:-

i. In the year 2006, M/s DePuy International Ltd., U.K. now M/s Johnson and Johnson Pvt. Ltd. (hereinafter referred to as the firm) has registered orthopaedic implants named ASR TMXL Acetabular Hip System and ASR TMHip Resurfacing System (hereinafter referred to as the device / implant / ASR) for import and marketing in India under the provisions of Drugs and Cosmetics Act, 1940 ( hereinafter referred to as 'Act') and Drugs and Cosmetic Rules 1945 ( hereinafter referred to as 'Rules').

ii. Many patients who have received the implant have started experiencing serious adverse reactions and had undergone revision surgeries, prematurely.

iii. Due to the higher rate of revision surgeries and serious adverse reactions across the world, the firm had recalled implants from the market globally.

iv. Many patients in India and across various countries have suffered due to serious adverse effects caused by ASR and have been forced to live a compromised life due to faulty implants.

v. The Committee looked into the various aspects relating to the design of the ASR, safety aspects, clinical aspects, reported serious adverse reactions, adequacy of the medical management and compensation, corrective & preventive action (CAPA) taken by the firm, action taken by the Central Drugs Standard Control Organisation (CDSCO) / State Licensing Authorities(SLA), negligence of the firm and other related aspects.

vi. The Committee, after deliberation of the issues and review of the documents, is of the considered view that the firm has been found to be evasive in providing the information desired by the committee regarding the design of the ASR, patient details including address, contact, compensation details, details of the usage of ASR, follow up Adverse Drug Reaction reports etc. The firm also appears to be delayed in passing information and awareness about the failure of the ASR.

vii. The Committee is of the considered view that the firm has neither provided the exact number of the patients who had undergone surgeries/re-surgeries with ASR nor they had stated categorically that they have approached each patient and informed them about the risks associated with the faulty ASR.

viii. The Committee is of the considered view that the patients had to live a restricted lifestyle with a compromised physical state thus putting them at pain and agony throughout their life which will also have a bearing on their dependents apart from loss of work. Though no amount of money can fill this void, however, the Committee feels that an opportunity should be given to make the claim for "just and adequate" compensation to each and every patient who had undergone revision surgery to mitigate some of their pain and sufferings.

ix. Medical devices are defined as "Drugs" under sub-clause (iv) of clause (b) of the Section 3 of the Act. Fifteen categories of medical devices have been notified so far under the said section of the Act. In order to ensure safety, quality and performance of notified devices, these are regulated for their manufacture, import, sale and distribution under the provisions of the Act and the Rules Orthopaedic implants is one of the categories of medical devices notified in the Gazette Notification vide SO. 1468(E) dated 06.10.2005 for its regulation under the provisions of the Act and the Rules.

x. For the manufacture, import, sale and distribution of notified medical devices, a licence from the Licensing Authority is required to be obtained under the provisions of the Act and the Rules. In case of import, an import licence (Form-10) is issued after the registration of the manufacturing site and device (Form-41) by the Licensing Authority, i.e Drugs Controller General of India [DCG(I)], under the provisions of the Rules.

xi. The ASR falls under the notified category of "orthopaedic implant" and is regulated under the provisions of the Act and Rules. The present issue relates with Articular Surface Replacement Re-Surfacing Hip System-Acetabular Implants, Femoral Implants. The ASR was registered by the DCG(I) for its import and marketing in the country since the year 2006 under the provisions of the Act and Rules.

xii. Consequent upon the global voluntary recall of the ASR initiated by the firm on 24.08.2010, the ASR was recalled globally as well as from India. Upon issuance of the showcase notice by CDSCO, the firm has thereafter surrendered the Registration Certificate and Import Licence for cancellation of the ASR product permission. Subsequently, DCG(I) had cancelled the product permission of the ASR for its import and marketing in public interest with a statement that the firm failed to take proper remedial measures, so that all the patients who had undergone "ASR Implant" surgery will have awareness that the recall is because of defectiveness of the ASR XL Acetabular Hip System and DePuy ASR Hip Resurfacing System.

xiii. Joint Commissioner, Food and Drug Administration, Maharashtra, after a joint investigation carried out by officials of CDSCO, West Zone, Mumbai along with FDA, Maharashtra on 10.05.2011 in response to a complaint received from FDA Commissioner, Maharashtra regarding the device in question informed the CDSCO about the filing of FIR. They stated that the firm has not taken proper remedial measures and that no awareness about the serious and defective implant and its ill effect on health was informed.

c. As per the information provided by the firm to CDSCO, around 93,000 people worldwide were implanted with ASR. On 24.08.2010, the firm recalled ASR due to a high rate of repeat surgeries or commonly termed as 'revision surgeries'.

d. The firm claimed that this 2010 UK data indicated that within five years of having an ASR resurfacing device implanted, approximately 12% of patients had revision surgery and that within five years of having an ASR total hip replacement, approximately 13% of patients had revision surgery, which was not in line with data previously reported in that registry. The firm, after reviewing the data, decided to recall the ASR voluntarily.

e. On 08.03.2010, the firm informed the CDSCO for sharing of Field Safety Notice (FSN) to the users of ASR. In this notice, the firm mentioned about an Australian report while stating that the data suggests that smaller head (less than 50 mm diameter) are associated with a higher rate of revisions (upto 8-9% at 3 years).

f. On 24.08.2010, the firm informed the CDSCO of their decision to voluntary recall ASR. The firm has submitted a copy of Field Safety Corrective Action letter and a copy of letter being issued to the surgeons in India. The firm mentioned that as per the unpublished data the revision rate for the ASR XL Acetabular Head System and DePuy ASR Hip Resurfacing System is approximately 12% and 13% respectively.

g. On 28.12.2010, the firm informed the CDSCO about total quantity of ASR imported in India (15829), the number of procedure performed (4700 since 2004), number of unused products (11129) that have been returned to the parent company and the date of the completion of recall (September 2010).

h. On 28.03.2011, the firm informed that the root cause of the higher than expected revision rate of the ASR product line is multi-factorial and not completely understood at this stage. The firm stated that they have launched an extensive investigation to identify the factors involved and the relationships between those factors that contribute to the higher than expected revision rate.

i. On 22.06.2011, the firm has submitted the progress regarding the voluntary recall and informed about Puri Crawford & Associates India Pvt. Ltd. which has been engaged for processing claims of patients and to reimburse patients and surgeons for the expenses incurred in the course of testing and any necessary follow-up treatment. The firm stated that 45 people in India had registered on ASR Helpline and details of the same were provided. Dates of communication with surgeons was also provided (First round took place during 26.08.2010 to 08 10.2010 and second round of communication during 01.03.2011 to 06.06.2011). The firm has provided work procedures, Urgent Field Safety Notice, Report of Crawford & Company and Letters to Health Care Professionals.

j. On 14.10 2011. the firm submitted details of the total number of patients worldwide wherein ASR has been implanted (approx. 93000). Out of this approximately 4700 is the number of patients for India as informed by the firm.

k. On 21.12.2011, the firm replied to this letter informing that they have set up a remedial and reimbursement process to guide ASR patients on the procedure to be followed with regard to testing, monitoring and revision surgery if any. They informed of the appointment of Puri Crawford for claims related to remedial and reimbursement process arising out of the recall. They stated that no injury has been caused and that the cost of surgery, visit to the doctor, testing charges and loss of job during the surgery has been compensated. The firm did not provide the patient details. The firm has provided the details of the patient registration (73) and reimbursements provided to patients till 12.12.2011 (Rs.10,959,780 for 31 patients). The firm informed that they do not have details of the patients who had undergone surgery since year 2004 till 24.08.2010 as this information is only available with surgeons, hospitals and is confidential and cannot be disclosed to third party.

l. On 26.04.2012. the firm has surrendered the original Form-41 and Form-10 for cancellation of ASR Re-Surfacing Hip System-Acetabular Implant. They also replied to the Show Cause Notice and denied that they have committed any wrong. The firm stated that there are reported data which suggests that the best total hip prostheses demonstrate a revision rate of approximately 1% per year. Thus at five years post marketing, one could expect a revision rate of about 5% or less. DePuy recalled the ASR because the data showed a five year revision rate of 12-13%.

m. On 11.07.2012, CDSCO thereafter cancelled the product import and marketing permission in public interest under the Act and Rules and further stated that the firm failed to take proper remedial measures, so that all the patients who had undergone "ASR Implant" surgery will have awareness that the recall is because of defectiveness of the ASR XL Acetabular System and DePuy ASR Hip Resurfacing System (ASR).

n. Between 10.01 2014 to 10.07.2014, the firm informed CDSCO about the details of certain patients during the period who had undergone revision surgery after submission of Adverse Event Reports. The adverse events indicated that patients who had undergone revision surgery had developed pain, limping, difficulty, severe pain in walking, soft tissue reactions and metallosis. These patients had to undergo revision surgery. Also on 12.06.2014, the firm had reported about 04 deaths of the patients who had undergone ASR surgery in the past.

o. On 04.08.2014, the firm has submitted the information as asked by CDSCO. The firm informed about the voluntary recall made by them in August 2010. They stated that since the recall decision was made, the firm has worked to provide patients and surgeons with the information and support they need. Upon perusal of the reply as submitted by the firm on 04 08 2014 CDSCO, has issued a query letter on 02.12.2014 regarding Untraceable Implants. The firm was requested to submit documents and relevant reports for following points:-

(i) It has been stated that approximately 4700 ASR surgeries were carried out in India out of which only 882 patients could be traced with ASR Helpline. These 882 patients account for a total of 1,056 ASR Hip Implant surgeries Action taken to trace out the remaining 3644 ASR Hip Implant surgeries need to be mentioned.

(ii) Reason has to be stated as to why the status and details of 21 patients who were registered with ASR Helpline but not included in medical records.

(iii) Status with various details of more than 2300 patients that had been able to reach out who underwent ASR surgery in India has to be submitted.

(iv) Mode of communication made for patient follow-ups need to be mentioned.

p. On 16.12 2014, the firm has submitted reply to the questions asked in the query letter dated 02.12.2014. They stated that only out of pocket expenses are reimbursed. In the meanwhile, when the CDSCO was taking up this issue with the firm, CDSCO/MOH&FW received some grievances on the ASR. As per the records, issue was taken up with the firm and the complainants were also informed about it. During this period, the matter was taken up with MOH&FW on several occasions and the information was provided to MoH& FW from time-to-time on this issue as sought by them.

Observations of the Committee in respect to the Terms of References (ToRs)

Ist TOR

(i) In the letter dated 26.04.2012 the firm had clearly admitted that a 5% revision rate is expected. However, they had recalled a product when the revision rate was 12-13% which is almost two and half times the normal rate. In this letter they had also stated that they had withdrawn the product on their own and nobody has directed them. However, as per the information provided to CDSCO by TGA, it has been stated that, the ASR hip prosthesis was removed from the Australian market in December 2009 after intervention by the TGA The TGA had acted upon data from the Australian National Joint Replacement Registry (NJRR) that showed an unacceptably high need for repeat joint replacement in patients who had received an ASR. The committee observed that this statement by the firm stands in contradiction with the information as provided by the TGA.

(ii) It is observed that the firm had not provided the detailed breakup of the ASR supplied under the excuse that multiple components are implanted during the single surgery and the number of components is much higher than the number of patients who received these devices. This has resulted in knowing about the number of surgeries only which is approximately 4700 conducted on the patient and not the exact number of patients on whom these surgeries have been conducted. This issue was also taken up with the firm on numerous occasions by CDSCO as well as by this Committee in the questionnaire sent to the firm. However, to the disappointment of this Committee, the firm has again avoided to provide the desired answer. It goes on to prove that there is something which the firm intends to hide and which reflects the non-cooperative intent of the firm. It is difficult to comprehend that the firm had no idea about the exact number of patients though they claim to have the knowledge of approximate number of surgeries conducted on patient. Had this been a case, how the firm has undertaken a recall exercise without knowing the number of patients in which the implants have been inserted. This simply goes on to prove that the firm is very much aware about the number of patients affected and is evasive in sharing this information to the regulator, CDSCO.

(iii) As per condition number 3 of the Registration Certificate issued to the firm by the CDSCO, it was mentioned that "the medical device will required to be withdrawn from the market in case any undesirable reaction due to failure of device or its accessories are brought to light at any stage. This Directorate should be informed of adverse reports on the medical device, if any." The firm had applied for import licence on the basis of the Registration Certificate on 11.01.2010. However, the fact that the ASR was already recalled in Australia in December, 2009, was not informed to the CDSCO even at the time of application for import licence. That the committee observes that there appears. to be suppression of material facts by the firm to the CDSCO. This is construed as a serious breach of a condition of approval.

2nd TOR

(i) The Committee observed that the firm has already discontinued/ removed the ASR in Australia in December 2009 after TGA intervention. However, this fact was not informed to CDSCO. Even in the letter dated 08.3.2010, inter alia the firm has only informed about published and unpublished data on revision surgeries of ASR implant. The committee is also of the considered view that the firm should have informed the fact that they have discontinued the ASR from Australian market. The fact of discontinuation was never informed to CDSCO and it was known only through TGA.

(ii) As per the written statement of the firm provided to the Committee, the firm offers free medical management / cost of 2nd implant for revision surgery and cost of that revision surgery. The firm, however, has not made any policy declaration for the compensation to be paid to all affected patients.

(iii) As per the data submitted by the firm to the committee, the firm informed that till March 2017, a total of 1063 patients got registered with the ASR helpline and out of which, 1032 patients found to have implanted with ASR implant. Till March 2017, a total of 254 patients have undergone through revision surgeries while 774 patients were kept on monitoring by surgeons. In addition, revision surgery is scheduled for 4 patients.

(iv) Though the firm has written the letter to doctors and dealers but lack of seriousness has been observed as the number of re-surgeries done are 254 and only 1032 patients could be traced and that too when patients made contact with the helpline. Therefore, the committee is of the considered view that the steps taken by the firm are inadequate.

3rd TOR

(i) In the FAQ of DePuy ASR Hip implants, they have admitted that in Australia, the class action has been settled for US$250 million plus interest including legal cost. They had also stated the Federal Court of Australia had found the settlement fair and reasonable.

(ii) The fact remains that no compensation ever has been made by the firm in India to any patient despite the fact that the implant is faulty and because of which the patients had to undergo multiple revision surgeries and had to live a compromised life. Instances like the present complaint of Mr Vijay Vojhola has brought notice to this fact that multiple revision surgeries has affected the lifestyle of not only the patients but also the dependent family members and has put enormous physical, mental, sociological, psychological and financial burden on the patients and their family members. In fact on being asked about compensation, the firm has only stated that they have provided reimbursements.

(iii) The committee observed that premature failure of an artificial hip implant puts the patients under serious and severe consequences of pain, difficulty in walking, his/her disability to engage in normal/routine activities and further in certain cases the need for another complicated and risky surgery to remove the artificial implants and replace it with another because of the failure with the another one. The committee observed that a revision surgery is a major operation entailing the risk of infection, loss of bone and other serious complications and after the surgery, patients need bed rest for few weeks during which time apart from enduring pain, the patients are unable to work or engage in their daily activities.

(iv) As a result of the faulty ASR implant inserted during initial hip surgery, the patient experienced agonizing pain, suffering and mental anguish, loss of work, traumatic experience and had to undergo physiotherapy and related treatments required for pain management apart from other medications. The patient after the insertion of faulty implant required medical care and attention as well as numerous visits to doctors because of the problems associated with the initial surgeries and subsequent surgeries. The patient will continue to require medical care and attention for a longer time because of the implant and it needs to be guaranteed by the firm as long as the problem persists. Many patients had already undergone a premature revision surgery or will require it in near future to remove and replace the faulty implant and may suffer serious consequences associated with the faulty implant as evident from the increased number of revision surgeries. Patients who require revision surgery are exposed to an increased risk of infection, bone reduction and other adverse consequences associated with the unnecessary hip surgery.

Recommendations

Considering all the facts and details as well as taking into account the relevant literature and the documents and information furnished by the firm, the detailed discussion referred to above, the Committee holds that the ASR hip implants manufactured by M/s DePuy International Limited, UK were found to be faulty which resulted in higher instances of revision surgeries globally including India. Accelerated wear of the MoM implant leads to higher levels of cobalt and chromium in the blood which may lead to toxicity. When the implant wears at an accelerated rate, the patient will experience local symptoms such as hip or thigh pain. These metal ions can damage tissues and further damage body organs. The excessive release of metal ions may also cause both localised and systemic health problems. This results in increased pain and decreases mobility affecting their family and social life, their ability to work, to undertake hobbies and leisure activities and often have a negative impact on their self-esteem and mental health.

Though the firm has taken some corrective measures by initiating reimbursement program for the patients, providing revision surgeries, however, the efforts undertaken by the firm has not been found to be adequate with respect to taking due care of all the patients, monitoring the follow-up of the patients who need the revision surgery and urgency in reaching out to all the patients. Further, the firm has failed to provide medical management to all the patients. In addition, the firm has not paid compensation to any patients so far as per the available records.

Compensation to ASR patients by the firm

The Committee is of the considered view that the revision surgeries were necessitated due to faulty ASR as well as negligence of the firm in approaching the patients and therefore, it is the responsibility of the firm to compensate all the affected patients. Grant of reimbursement as stated by the firm cannot be equated with compensation. The Committee accordingly recommends that the firm be made liable to pay adequate and just compensation commensurate with severity of the pain, the resultant disability, sufferings ( both mental and physical) and with the loss of wages of each of the patients who had received ASR.

The Government accepted the recommendations of the Expert Committee with certain modifications for constitution of Regional Committees etc.

9. Based on the recommendations of the Agarwal Committee Report, Government constituted a Central Expert Committee under the Chairmanship of Dr. R.K. Arya, Director, Sports Injury Centre to determine the quantum of compensation. All the States / UTs were also asked to form state level committees to examine the effected patients within the respective states and to make process less arduous for the patients. These Committees were to send recommendations to the Central Committee. Arya Committee had series of meetings and prepared a formula for determining compensation for the ASR victim patients, which is as follows: -

BxRxE + Rs.10 lakh towards non pecuniary damages

Where B is the basic amount i.e. Rs.20 lakhs

R is the Risk factor

F is the Age Factor

The Risk and Age factor recommended were as follows:-

Percentage Disability

Risk factor to be assigned

20%-30%

30%-40%

1.5

40%-50%

50% & above

2.5

Age Factor ( F)

Age

Factor

228.54

227.49

226.38

225.22

224.00

222.71

221.37

219.95

218.47

216.91

215.28

213.57

211.79

209.92

207.98

205.95

203.85

201.66

199.40

197.06

194.64

192.14

189.56

186.90

184.17

181.37

178.49

175.54

172.52

169.44

166.29

163.07

159.80

156.47

153.47

149.67

146.20

142.68

139.13

135.56

131.95

128.33

124.79

121.05

117.41

113.77

110.14

106.52

102.93

65 & more

99.37

The Government accepted the formula prepared by the Central Expert Committee.

10. Objection of the OP against Expert Committee Report /observations and recommendations of the Expert Committee are as under:-

(a). Drugs Technical Advisory Board ("DTAB") and Drugs Consultative Committee ("DCC") are the statutory technical bodies as per Section 5 and section 7 of the Drugs and Cosmetics Act, 1940 respectively to render technical assistance to the Government on matters and issues arising under the Act. MoH&FW and the DCGI have wrongly by-passed the legal procedure set out by the Act. The DTAB/DCC being the only statutorily designated authorities to advise the Central Government on matters related to the sale and performance of drugs and medical devices in the present case. The Aggarwal Committee, formed by the MoH&FW, was tasked with the objective of conducting a technical inquiry and give its recommendations to the Central Government. This Committee was not in the nature and composition of the DTAB and stands alone appointed committee. The said committee was constituted contrary to the provisions of the Act. Thus, the very incorporation of the said Expert Committees is ultra-vires the provisions of the Act and Drugs and Cosmetics Rules 1945, and does not have requisite jurisdiction and powers to act in the matter as envisaged.

(b). Expert Committee was neither a Drugs Technical Advisory Board (DTAB)/Drugs Consultative Committee (DCC) nor the statutory committee of inquiry. Expert Committee was an adhoc committee with no statutory basis. Since the scope of review entailed was technical in nature, the DTAB was the proper statutory Committee which should have been mandated to conduct the aforesaid investigation. Said Committee was established under following terms of reference:-

"To assess all pertinent issues relating to Faulty ASR Hip Implants manufactured by M/s DePuy International Limited UK.

To review actions by the firm to replace the faulty ASR Implants and adjudge adequacy thereof.

To review the Medical Management and compensation provided by the firm to the victims of Faulty ASR Implants.

To review all Adverse Event reports of Faulty ASR Implants and Corrective and Preventive Action (CAPA) taken by the firm.

To make specific recommendations to the Government on further course of action in the matter in the light of the entirety of facts.

To assess the regulatory action taken by NRA's from ICH[1] countries on faulty ASR Hip Implants."

(c). The reference does not contain the mandate to examine the subject implant scientifically in any appropriate laboratory or to render any finding about the defect. With a presupposed conclusion that ASR Hip Implants were faulty, the committee was tasked to address the issue of Faulty ASR Hip Implants by conducting a technical evaluation of the ASR Hip Implant and examine the issues related to recall thereof.

There was no scope for the committee to examine whether the implants were faulty. The Committee therefore neither had the mandate nor did it examine the subject implant scientifically in any appropriate laboratory nor have they rendered any test to find out the defect in the implant. The finding about defect in implant is without any basis or technical evaluation.

The allegation of fault of the implant can only be proved by testing of the implant in accordance with the procedure prescribed under law. The onus thereof lies on the complainant and is accordingly required to be discharged by the complainant. The complainant has alleged a defect in the product. Such defect needs to be determined with proper investigation, analysis and / or testing before any conclusive determination of fault is made. The process for analysing the implant in question for alleged fault has not been followed. The Complainant is misconstruing the Expert Committee's Report as a finding on defect of the implant instead of discharging the onus cast on her.

(d) The OP gave the reason for the recall in Field Safety Notes, as the data received by it from the Australian NJRR and UK NJR which showed a higher rate of revision surgery than expected. The OP maintained in both the FSN's that the longevity of an implant depended upon a multitude of factors including surgical technique, patient selection, rehabilitation, physical and medical condition of the patient including many pre-existing issues and ailments etc. In pursuance of this, the OP had also issued detailed technical guidelines to clinicians regarding optimum use of the implant and the suggested surgical procedures to be adopted for the same. The Form submitted to the DCGI on 24.08.2010 and the FSN on the same day was only to inform the concerned clinicians/hospitals/patients as well as DCGI regarding the voluntary recall of the Implants and can in no manner be construed as an admission of failure of the Implant by the OP. The Committee has dismissed the submissions of the OP in this regard and the report incorrectly interprets the voluntary recall as a product failure as observed therein to the extreme prejudice of the OP.

(e)

The OP submitted detailed technical and scientific data by way of presentation that is a reference point for technical knowledge in the industry which are relied upon by the experts in the industry. However, the Expert Committee has failed to consider the presentation of the OP and ignored to consider information which is otherwise available widely in the industry.

(f) Based on the observations made by certain orthopaedic specialists, Expert Committee held that the Implants were faulty, whereas no proper details regarding the basis of the same have been provided in the report. The OP was neither invited to any meeting with such experts, nor was it given an opportunity to discuss the position of the Committee's experts to assist them in understanding the design rationale, bench top testing and clinical monitoring of the Implants. Reliance by the Committee on these statements without any technical background and most importantly without affording the OP the rightful opportunity of responding to these incorrect observations of the specialists is and against the very principles of natural justice that govern the examination of subject matter specialists. The inference of fault as ascribed to the Implant of the OP is therefore incorrect and devoid of any rational basis.

(g) Expert Committee found that the OP had admitted failure of its product as metal wear and tear causes elevated release of metal beyond seven parts per billion.

The contents of this paragraph are denied as being false. Since the 1970s, the regulators around the world have cleared various implant systems with cobalt chromium alloys, including joint replacement implants. Millions of joint replacements with components made of these alloys have been implanted; indeed, cobalt chromium alloy implants are an industry standard worldwide. Cobalt can only lead to health issues in other areas of the body at extremely high levels that are rarely found in implanted patients. Regardless of whether they have an implant, every person has some cobalt and chromium (III) in their body. Chromium (III), which is the form of chromium found in metal hip implants, is an essential nutrient that assists the body in using sugar, protein and fat. Cobalt is also essential to health as it forms part of Vitamin B12. It is found in many foods, including green leafy vegetables, cereal, waffles and potato chips. The threshold level of cobalt necessary to lead to any systemic health effects is generally believed to be extremely high and has rarely been reported even in metal-on-metal hip replacement patients. Cobalt can only lead to systemic effects at extremely high levels that are rarely found in implant patients. Chromium (III) is non-toxic in nearly all circumstances. There is no known level of chromium. The release of metal debris caused due to wear and tear is associated with all MoM implants and has been the case since decades. Cobalt and Chromium are regarded as bio compatible materials. In fact, there is enough medical evidence which suggests that chromium and cobalt are suitable metal for being used in implants. Orthopaedic implants made from these materials have been extensively studied and tested for use in the body.

(h) Among the patient related factors are the activity level; lifestyle, hobbies, occupation; general health, comorbidities; and the individual physiological and immunological thresholds for response to surgery and implants and resulting by- products such as wear debris. It is unclear at this time that if there was/is a difference in patient to patient reactivity to metal wear debris and the amount of metal wear debris. It is generally understood that there may be patient to patient variability but that it is not predictable at this time and the association with adverse local tissue response (ALTR) is unclear and deserves more research. There appears to be more than one type of local response to the presence of metal by-products, including an extreme response to a small amount of debris i.e. "hypersensitivity" and a proportional response based on the amount of debris present. This adverse local tissue response has not been consistently correlated to any particular pattern or mode of wear or to any discernible implant design factor. Recently published research showed that the patient related factors such as genetics, response to metal debris, difference in adverse local tissue reaction may contribute to understanding cause for revision when reasons such as infection, dislocation and malignant, are set aside.

(i) The committee randomly selected 101 patients and sent letters to them; out of which only 22 patients responded, out of which only a certain number underwent revision surgery, while there were many patients who had no problems arising out of the implant even after revision surgery. Based on these facts, the Expert Committee concluded that most of the patients had to undergo revision surgery more than the normal. The Committee reached its findings and extrapolated them based on a mere sample of patients from the list that was submitted by the OP. The Committee failed to note the extremely low rate of responses that were received to its letters, thereby establishing the fact that not all patients have issues arising as a result of the Implants. The Committee has further not taken into account the fact that some patients in this random list of patients reported that they do not have any issue with the Implant post revision yet the Committee proceeded to observe against the OP. As regards the patients who have reported to have undergone revision surgeries, it was submitted that the Committee did not go into the reasons behind such revision surgeries and did not assess whether such revision surgeries were necessitated solely because of the Implant or because of reasons not attributed to the Implant itself. The Committee further did not review the medical histories of such patients and simply chose to summarily accept the admittedly minuscule amount of information (22 out of 101 patients). The information provided at the first instance, attribute fault to the Implant and accuse the OP without affording any opportunity to provide its response to this information as obtained. Therefore, the conclusions drawn out in the Report are without recourse to the OP, based on incomplete data, devoid of any basis and as such are objected to.

(j) The OP gave adequate warning to the users about the harms posed by the Implants. All relevant information about the correct procedure to use the Implant was provided to the surgeons/clinicians. 'Information for Use' ("IFU") for surgeons for the Implant extensively described the correct procedure to use the Implant in surgeries which is essential for proper functioning of the product.

The following information was included in the IFU:-

Description of product

Indication for use

Contraindication

Information for use (reference to surgical technique manual)

As per the IFU, surgeons should refer to the surgical technique manual before implantation.

Warning

Precaution

Adverse effect

Handling instructions of product

(k) There was no recall in Australia in 2009. In Australia, the decision to discontinue ASR sales was announced in letters to customers in late 2009 and was communicated in writing to the TGA in early December 2009. The decision to discontinue the Implant from the Australian market was based on the fact that there was limited demand for the Implant at the time. The observations of the Committee as regards the reasons for discontinuation of the Implant from Australia owing to intervention by TGA are incorrect. In this regard, it is submitted that till August 24, 2010, when the global company of the OP announced the voluntary and worldwide recall, the totality of data available with the global company showed that the implant was performing consistently with the class of large diameter mono-block MoM hip implants. The Australian TGA, has itself in its letter dated 25.01.2019, confirmed that the TGA did not classify the actions that were taken in 2009 as a 'Recall'. The actions that were taken in 2009 by the OP herein were only considered to be a 'Product Withdrawal'. It was further confirmed by the TGA that the Uniform Recall Procedure for Therapeutic Goods specifically states that 'Product Withdrawals' are not 'Recalls' and the safety alerts like the one from April 16, 2010 are also not considered as 'Recalls'. The action which can be classified as recall was taken on August 25, 2010 and this was a worldwide recall action by the OP in the true sense of the term recall. At the time of this voluntary global recall, the ASR Hip Implants had already been withdrawn from supply for above stated commercial reasons of low sales.

(l) OP-2 is not in a position to provide the exact break-up of the patients who had undergone the implant procedure. Firstly, it is not possible to provide the exact details of the patients fitted with the Implant because of non- availability of hospital records, since OP-2 only supplied the Implant to the hospitals who keep a further record of their utilization during surgeries. OP-2 can only rely upon data pertaining to secondary sales (retailing data) from the distributors to get information regarding supplies made to hospitals. Secondly, the allegations levied against OP-2 that it is hiding these figures and is being non-cooperative is false and baseless as OP-2 has duly provided all requisite materials and documents to the Government as and when required.

m. A plain reading of the report from its preface and terms of reference itself would show that the reference was not for examining the patient or give a finding as to whether the product is defective, rather the reference was for devising a procedure for dealing with issues arising out of implants and to provide a mechanism for reviewing the medical management and compensation provided by the firm to the patients. Therefore, the Expert Committee's report is not a piece of evidence to establish that the implant in each individual was defective. The Expert Committee's report has not examined any of the patients to analyse their sufferings nor have they tested a single implant on any of them. Therefore, Expert Committee's report is not an admissible and credible evidence for buttressing or establishing the allegations of the individual complainants before this Commission.

n. The OP provided its explanation to the Expert Committee vide its letter dated 06.05.2017, that there was no definitive product design/material which was the root cause for the higher revision rate of the Implant. Survivorship of any joint replacement implant system depends on a multitude factors, including careful adherence to surgical technique, patient selection (bone quality) and rehabilitation procedure. Each Implant case requires precision oriented procedures to ensure proper positioning of the same which results in proper functioning within desired parameters, each revision is a unique case and requires detailed analysis to understand the potential causes of revision and specific action to be taken in this regard. The success of any total hip replacement surgery is dependent upon three factors: device (including design and manufacture), surgery (including surgeon and surgical technique) and patient (including medical history including comorbidities and post-surgical activity level and compliance with surgeon instructions). Higher patient activity level post implantation has been associated in general with higher wear and tear of Implants which, in-turn may also increase the propensity for revision. Similarly, some studies suggest that cup inclination angle of the Implant during surgery, which can vary widely by patient due to factors such as anatomy and surgical technique, has been associated with higher wear, thereby increasing the propensity for revision. The OP submitted detailed technical and scientific data by way of presentation that is a reference point for technical knowledge in the industry. These are relied upon by experts in the industry.

o. The present matter involves a product with complex technical aspects, having multiple modular and component variations, detailed technical specifications and is a highly engineered complex piece of equipment. It is absolutely imperative to understand, assess, evaluate the workings of the modular components, placement thereof in the body, procedures, pre-operative, operative, post-operative, pre-existing conditions of the patient, anatomical makeup of the patient, lifestyle of the patient and other technical parameters in relation to the functioning of the said Implant before any conclusion as regards fault can be established in the matter. All of these are factual aspects that require detailed examination and evidence. It is humbly submitted that the EC Report has failed to do so. The EC Report is document that is full of conjectures and surmises that are drawn from a pre-supposition of fault and bias, not to mention illegality. The Complainant basing reliance on the said EC Report has failed to discharge the onus of proving fault as cast on him. The EC Report cannot be relied upon as proof of fault.

p. The mandate given to the Expert Committee was pre-concluded fault. The Expert Committee moved ahead with the pre-ordained conclusion and proceeded to assess remedial measures taken by the OPs. Fault was never investigated. Fault was pre-supposed. The EC Report merely relies on weak testimony of an alleged set of experts (two), which testimony in itself is in the form of speculative statements to the extent that the implant appears to be faulty. While one expert make a speculative statement in this regard, interestingly another expert has opined that metal on metal implants have been in use since 1950 and no complaints were received.

q. Even though the Expert Committee wrote to multiple regulatory agencies across the world, not even a single agency responded in the affirmative on the issue of fault as attributed to the Implant. On the contrary the Australian Regulatory Agency-TGA opined that data and its analysis advised that higher rates of revision was most probably due to the technical complexity of correctly fitting (sitting) the device.

r. The Expert Committee based its allegations of defects on the basis that there were increased revision surgeries. The Expert Committee ignored the fact that reasons for revision surgeries depend on an array of factors as clarified by the Answering Respondent /Company. The Expert Committee ignored the information submitted by the Answering Respondent which contained detailed technical and scientific data regarding hip replacement surgeries, revision surgery and the various factors which affect the success of both these types of surgeries.

s. 4th Meting : No deliberations on establishing fault. The Committee itself referring to implants as fault in the minutes.

t. Recommendations of committee primarily deal with issue of fixing compensation. There has been no finding on fault by the Committee. Furthermore, without prejudice, even the report evinces that the compensation is not to be granted to each and every patient, and the same has to be decided after consideration on a case to case basis.

u. The EC Report contains disputed questions of fact, the same require judicial adjudication and cannot be relied upon by this Commission as the role of Expert Committee or any report arising therefrom, the facts of which are disputed would not substitute the adjudicatory role of the Commission. This Commission is the competent judicial body that is required to delve into facts of the matter relating to fault and should not base its conclusion on a simple statement of fault basing reliance on the EC Report. The complainant is attempting to set up a case that fault as a fact has already been adjudicated by the Expert Committee. This fact needs to be conclusively proven after a proper investigation and adjudication by this Commission qua facts thereof.

11. The OP filed Writ Petition (Civil) No.13395 of 2018 before Delhi High Court challenging Expert Committee report dated 19.02.2018. The MoH&FW, acting in furtherance of recommendations of the Expert Committee, constituted another technical committee under the chairmanship of Dr. R.K. Arya ("Arya Committee") to examine the issues related to payment of compensation to ASR Hip Implant patients and give recommendations to MoH&FW in this regard. The Arya Committee recommended a formula and process for payment of compensation vide a report "Arya Committee recommendation/ Formula", released by Government of India on 29.11.2018 in a press release note. On the basis the recommendations of the Arya Committee, the MoH&FW, issued compensation orders to the OP vide letter/order dated 30.11.2018 directing to pay compensation to patients who had been implanted with the ASR Hip Implant. The OP filed Writ Petition (Civil) No.3523 of 2019 and Writ Petition (Civil) No.4691 of 2019, challenging individual compensation orders on the basis of above report. Delhi High Court vide order dated 20.03.2023, observed that if the report of expert is sought to be relied upon before any other court/forum then the concerned court would consider the objection of the OP against this report.

12. We have considered the arguments of the counsel for the parties and examined the record. The Consumer Protection Act, 1986 (hereinafter referred to as the Act) was enacted with an object to provide for better protection of the interests of the consumers and for that purpose, consumer council and other authorities for settlement of consumer disputes have been established. Section 13 (4) confers same powers for trial of the dispute upon the authorities under the Act, which are vested in Civil Court under Code of Civil Procedure, 1908, while trying a suit in respect of (i) the summoning and enforcing the attendance of any defendant or witness and examining the witness on oath, (ii) the discovery and production of any document or other material object producible as evidence, (iii) the reception of evidence on affidavits, (iv) the requisitioning of the report of the concerned analysis or test from the appropriate laboratory or from other relevant source, (v) issuing of any commission for the examination of any witness and (vi) any other matter which may be prescribed. Although under the Act, the jurisdiction of the authorities is limited to consumer dispute, but while deciding such dispute no limit has been fixed for adjudicatory power. The authorities are conferred jurisdiction to decide the issue of "unfair trade practice" which has been defined under Section 2 (r) of the Act. From these provisions it is clear that this Commission can hold a full trail as held by civil court or adopt summary procedure for decision of any complaint. In the present case, none of the parties has demanded for full trial as held by civil court and both the parties have adduced their evidence in the shape of affidavit and documentary evidence. None of them sought for cross examination of the deponents of the affidavit or for summoning of any other witness. A Bench of three Judges of Supreme Court in Dr. J.J. Merchant Vs. Shrinath Chaturvedi, (2002) 6 SCC 635, (paragraph-7) held that the object and purpose of the Act is to render simple, inexpensive and speedy remedy to the consumer with complaint against defective goods and deficient services, it being a benevolent piece of legislation, intended to protect a large body of consumer from exploitation. Consumer Forum is an alternate Forum, established under the Act, to discharge the function of Civil Court. The argument that the complicated question of fact cannot be decided by the Forum, has been specifically rejected (In paragraph-12). Similar view has been taken in Amar Jwala Paper Mills Vs. State Bank of India, (1998) 8 SCC 387, CCI Chambers Coop. Hsg. Society Ltd. Development Credit Bank Ltd. (2003) 7 SCC 233. This view has been reaffirmed by three Judges Bench of Supreme Court, in Nizam Institute of Medical Sciences Vs. Prasanth S. Dhananka, (2009) 6 SCC 1 and IFFCO TOKIYO General Insurance Company Ltd. Vs. Pearl Beverages Ltd., (2021) 7 SCC 704.

13. The OP submitted that first surgery for total hip replacement of the complainant was done on 02.04.2009. ASR XL hip was recalled on 24.08.2010 and the complainant was informed about the remedial step on 29.11.2010. The complaint was filed on 24.04.2015. Section 24-A of the Act provides two years limitation for filing the complaint. As the complainant did not file any application for condonation of delay and as such the complaint is liable to be dismissed as time barred.

The complainant stated that defect in the implant was noticed in the year 2014. The complaint was filed within two years from the date of defect being noticed. Section 17 of Limitation Act, 1963, provides that in case fraud and mistake, limitation starts running from the date on which fraud or mistake came in the knowledge of the plaintiff. Supreme Court in V.N. Shrikhande (Dr) Vs. Anita Sena Fernandes, (2011) 1 SCC 53, held that where effect of medical negligence was manifest, cause of action arises on the date, when negligence was committed. However, where effect is latent, cause of arises when harm or injury is discovered. In Hyundai Motors India Limited Vs. Shailendra Bhatnagar, 2022 SCC OnLine SC 483, held that limitation would start running from the date, the defect was surfaced. In Jay Laxmi Salt Works (P) Ltd. Vs. State of Gujarat, (1994) 4 SCC 1, held that in cases of malfeasance, misfeasance and non-feasance, limitation can be computed from the date of occurrence or from the date damage took place or the date when is rejected.

Admittedly the OP announced reimbursement programme on 24.08.2010, for 7 years, which was extended for further 5 years. On 02.05.2019, the OP gave statement before Delhi High Court, they would pay Rs.25/- lacs to all the patient, who had undergone revision surgery. Therefore, it cannot be said that this complaint is time barred.

14. The OP argued that Section 13(1)(c) of the Act requires to obtain analysis test from appropriate laboratory in order to determine the defect in the goods. In the present case, neither the complainant applied for obtaining a report from medical laboratory in respect of ASR hip implant nor the Commission has obtained any such report. Relying upon the judgments of Taylor Vs. Taylor (1875) 1 Ch.D. 426, Nazir Ahmed Vs. Emperor AIR 1936 PC 253, Shiv Bahdaur Singh Vs. State of of Vindhya Pradesh AIR 1954 SC 322, State of U.P. Vs. Singhara Singh AIR 1964 SC 358, Chandra Kishore Jha Vs. Mahavir Prasad (1999) 8 SCC 266, Dhananjay Reddy Vs. State of Karnataka (2001) 4 SCC 9, Gujrat Urja Vikas Nigam Ltd. Vs. Essar Power Ltd. (2008) 4 SCC 755, Dipak Babari Vs. State of Gujarat (2014) 3 SCC 502, Hussein Ghadially Vs. State of Gujarat (2014) 8 SCC 425, J. Jayalalitha Vs. State of Karnataka (2014) 2 SCC 401, State of Rajasthan Vs. Mohinuddin Jamal Alvi (2016) 12 SCC 608, Cherukuri Mani Vs. Chief Secretary Govt. of A.P. (2015) 13 SCC 722, Municipal Corporation of Greater Mumbai Vs. Abhilash Lal (2020) 13 SCC 234, OPTO Circuit India Limited Vs. Axis Bank (2021) 6 SCC 707, submitted that when law prescribed a particular mode for doing an act then it has to be done in that manner alone and in no other manner.

The principle of law as declared in above cases relates to discharge of statutory function by a statutory authority. Section 13(1)(c) of the Act is not a rule for discharge of statutory function rather a rule of evidence for the parties. Such a report obtained from a laboratory is not a conclusive proof rather it can be proved as not reliable under Section 13(1)(f) of the Act. Section 13(1)(c) of the Act, is not exhaustive of other rule of evidence. The complainant can prove latent defect in ASR hip implant by other evidence. Supreme Court in Ajay Kumar Parmar Vs. State of Rajasthan (2012) 12 SCC 406, held that in the absence of expert evidence the court has to form its opinion and standard literature on the subject. In Sunita Vs. Rajasthan SRTC (2020) 13 SCC 486, held that in civil proceeding, best evidence rule is not applicable and the court is required to form its opinion of the evidence available on the record.

15. The counsel for the OP submitted that constitution of Expert Committee by the Government was illegal. Section 5 and Section 7 of the Drugs and Cosmetics Act, 1940 authorise Central Government to constitute 'Drugs Technical Advisory Board' and 'Drugs Consultative Committee', respectively. Section 5(5) authorises 'Drugs Technical Advisory Board' to constitute a sub-committee for consideration of a particular matter. Thus the Drugs and Cosmetics Act, 1940 expressly permits constitution of other committee, apart from 'Drugs Technical Advisory Board' and 'Drugs Consultative Committee'. Central Government was competent to form Expert Committee and its formation cannot be challenged on the ground that its chairman was not an expert of the subject, for which it was formed. Supreme Court in Rajeev Suri Vs. Delhi Development Authority, (2022) 11 SCC 1, held that broad structure of administration and governance of state is premised on the notion that the task of administration is not sole virtue of a select few, who are experts in a particular field of study. Multiple factors came into play when the administration is entrusted to particular office and it is not for the court to prescribe a qualifying criterion for discharging the functions assigned to a particular office.

16. The OP in "Information For Use" gave 'adverse effects' due to improper positioning, histological reasons and improper head side selection. The OP stated that on 08.03.2010 DePuy UK received reports from Australian National Joint Replacement Registry ("NJRR") which suggested that smaller heads (less than 50 mm diameter) are associated with a higher rate of revision surgery (8-9%). Then the OP issued Field Safety Notes dated 08.03.2010 and 24.03.2010. Again DePuy received unpublished data in July 2010, from National Registry of England & Wales suggesting that five-year revision rate for ASR Resurfacing System was approximately 12% and for the ASR XL Acetabular system was approximately 13% across the entire size range and further that the revision rate was highest with ASR head sizes below 50 mm in diameter and among female patients. Given this higher than the expected revision rate, the DePuy Medical Private Limited voluntarily recalled the entire range of ASR Hip Implants globally including from the Indian market vide their letter dated 24.08.2010 but denies that recall was due to any defect.

17. The OP, along with its written reply has filed a copy of instructions issued by U.S. Food and Drug Administration (pg 98), stating as:-

"Orthopaedic Surgeons take several precautions before and during the implantation surgery to try to optimize the way in which ball and socket rub against each other, so that fewer wear particles are produced. However, there is no way to fully avoid the production of metal particles. Different people will react to these metal particles in different ways. At this time, it is not possible to know who will experience a reaction they might have, when the reaction will occur or how severe the reaction will be. However, it is known that overtime, the metal particles around some implants can cause damage bone and/or tissue surrounding the implant joint. This is sometime referred to as an "adverse local tissue reaction" (ALTR) or an "adverse reaction to metal debris" (ARMD). Such a reaction may cause the implant to become loose or cause pain. Ultimately this can require a revision surgery, where the old device is removed and replaced with another one.

In additional to these reactions to metal near the joint and implant, there are some case reports in the literature of a small number of patients in which high levels of metal ions in the bloodstream may have cause other types of symptoms or illnesses elsewhere in the body, including effects on the heart, nervous system and thyroid glands.

Patients who have metal-on-metal implants should be aware of potential symptoms which may occur after surgery and indicate that their device is not functioning properly. Common symptoms may include: Pain in the groin; swelling at or near the hip joint; and a limb or change in walking ability."

18. The OP, in warning, attributed 'adverse effects' due to improper positioning, histological reasons and improper head size selection. The purpose of implant is that after implant, the patient can walk, sit and sleep without pain. In metal-on-metal implant, in every movement of implant, there will be fiction and create metal particle. The reasons for fiction as mentioned in the warning are not correct. U.S. Food and Drug Administration clearly mentioned that there was no way to fully avoid the production of metal particles in metal-on-metal implants. The metal particles around some implants can cause damage to bone and/or tissue surrounding the implant joint which is sometime referred to as an "adverse local tissue reaction" (ALTR) or an "adverse reaction to metal debris" (ARMD). Such a reaction may cause the implant to become loose or cause pain. High levels of metal ions in the bloodstream in some patients may cause other types of symptoms or illnesses, including effects on the heart, nervous system and thyroid glands.

19. Not only the OP recalled its product but also came with a remedial scheme for the affected patients. In the remedial scheme, there is one letter, headed as "Information for Patients", which states as "If you have just had a hip replacement. But if the symptoms continue or come back, it is sign that there may be problem such as Loosening, when implant does not stay attached to the bone in right position; Fracture, where bone around the implant may have broken; and Dislocation where the two parts of the implant that move against each other are no longer aligned. Your hip implant is made up of ball and socket components that move against each other. These components are made of metal that wears over time and generates very small particles that can only be seen with a microscope. That is an expected process. Different people respond to the particles in different ways. A small number of patients may react to these particles, causing fluid to collect in the joint and in the muscles around the joint. While this condition may initially be painless, if left untreated, this reaction may cause pain and swelling around the joint and damage some of the muscles, bones and nerves around the hip."

"The evaluation may include a blood test that indicates the level of microscopic metal particles around your hip. If the blood test indicates a high level of these particles, your surgeon may want to do a second blood test three months later. These levels may be high even if you are not experiencing any symptoms, so this blood testing is very important. If the second blood test still indicates a high level of these particles, your surgeon may want to do MRI or ultrasound test of your ASR hip. If such test shows a reaction of particles, your surgeon may recommend surgery to replace your implant."

In letter dated 24.08.2010, the OP mentioned reasons for revision identified within the datasets were consistent with previously reported for ASR and include component loosening, component malignant, infection, fracture of the bone, dislocation, metal sensitivity and pain. If these reasons are co-related with the remedial measure and the instruction of U.S. Food and Drug Administration, then there appear no other conclusion except that metal-on-metal implant was creating metal debris at the joint, which was root cause for component loosening, component malignant, infection, fracture of the bone, dislocation, metal sensitivity and pain, in at least 13% patient and mostly in females.

20. The OP sold the ASR hip implants to the surgeon/hospital. "Information For Use" was supplied to the surgeon/hospital and not to the patient. Hip Replacement surgery was done by the highly qualified and experienced doctors. The OP neither alleged that the doctor had committed negligence in conducting Hip Replacement surgery in proper positioning or in selection of proper head size nor cross-examined any of the doctors. Histological reasons of the patients can be verified from their medical record. The surgeon in his reply has not alleged that the patient had not taken post-operative care. The OP adopted "plea of not guilty and innocence", which is not applicable in civil proceeding. It is not a natural conduct that the OP considered only the revision data and not the reason for revision surgery, at the time of recall. But due to business strategy, the OP is now claiming that ASR hip implant was not defective as in more than 85% patents, it had no side effect. If the evidence of the patient shows metal debris and complications and remains un-rebutted, then it can be safely relied upon.

21. The complainant placed on record a copies of the judgment dated 22.03.2013 of Superior Court of the State of California in Sandra Ellis, Loren Kransky and Others Vs. DePuy Orthopaedics Inc. (Case No. BC 456086) and Court of Appeal of State of California in CA/2/7, B249576 Kranskey Vs. DePuy Orthopaedics, dated 21.07.2016.

Above case was filed as class suit by 100 plus persons including Loren Kransky against DePuy Inc. and others vide suit filed on 18.02.2011. The matter pertained to DePuy ASR Acetabular Hip Systems and DePuy ASR Hip Resurfacing Systems and it was alleged that patients who received DePuy Acetabular Hip Systems experienced pain, popping, grinding, lack of mobility, metal sensitivity, loosening of the prosthesis, misalignment of the prosthesis, infection, dislocation, bone fracture, high metal ion levels in their blood streams, cyst formation and the necessity for revision surgery to explant the DePuy ASR Acetabular Hip Systems and the DePuy ASR Hip Resurfacing Systems and replace them with non-defective products. It is stated in the complaint that on or about August 24, 2010, the DePuy ASR Acetabular Hip System and the DePuy ASR Hip Resurfacing systems were recalled and the defendants knew for years before issuing the recall that the patients using these systems were experiencing the symptoms discussed above. It was alleged in the complaint that plaintiff's injuries were caused by defects in the implant. The defects in each of the implant system used by various plaintiffs arise directly from the same manufacturing, designing, formulating, constructing, rebuilding, fabricating, producing, marketing, assembling, selling and / or distributing practices by the defendants. Each plaintiff's similar injuries were caused by the same injury - causing process specifically the implantation of a defective hip implant device. The plaintiffs alleged that negligence of defendants was a substantial factor in causing plaintiff's harm. It was further alleged that said implant system contained a manufacturing defect and such defect was a substantial factor in causing the harm to plaintiffs. The said implant system did not perform as safely as an ordinary consumer would have expected at the time of use, and the design of implant system was a substantial factor in causing harm to the plaintiffs. The defendants failed to adequately warn of the potential risks of the implant system, the defendants failed to adequately test the said implant system to ensure that devises were not prove to be early failure and that they would not cause metal contamination of patient's body and connected problem. The defendants claimed the implant systems were state of the art orthopaedic hip implants that would last 15-20 years and would not cause pain, popping etc. and so on.

The Superior Court of California/Jury vide its judgment dated 21.03.2013 in the case of Loren Kransky Vs. DePuy Orthopaedic Inc gave the verdict by answering the certain questions as follows:-

i. At the time of sale, was the DePuy ASR XL used in Kransky's procedure defective because of its design ? - Yes.

ii. Did the defective design of the DePuy ASR XL cause injury to plaintiff Loren Kransky? - Yes.

iii. Was the ASR XL sold in a defective condition because of a failure to adequately warn of those dangers which would not be readily recognized by Mr. Kransky's treating physician - No.

iv. Did DePuy Orthopaedics Inc. fail to act as a reasonable medical device manufacturer in the design or warnings of the ASR XL - Yes.

v. Did DePuy Orthopaedic Inc's failure to act as a reasonable device manufacture in the design or warning of the ASR XL implant cause injury to Plaintiff Loren Kranky? No.

vi. Was Plaintiff Loren Kransky suffered injury to his person through the fraud as malice of DePuy Orthopaedics - No.

vii. Damages awarded by the Court to Plaintiff Loren Kransky.

(a) Economic Loss

(i) Medical Expense $3,38,136.12

(b) Non medical loss, including physical $80,00,000

Pain and emotional suffering and distress

c. Punitive damages : Nil

Total damages awarded after deductions $82,60,790.85 along with costs.

Judgement of Court of Appeal of State of California in CA/2/7, B249576 Kransky vs. DePuy Orthopaedics, Inc. dated 21.07.2016

DePuy Orthopaedics had filed an appeal against the judgement of Superior Court in the Kransky case in which the jury had found DePuy strictly liable for the defective design of a hip implant of Kransky. During the pendency of the Appeal, Kransky died on 26.02.2014. In appeal, DePuy had challenged several evidentiary rulings, including exclusion of evidence related to hip implant's clearance by FDA for sale in the US, and admission of certain testimony of Kransky's expert witness and his treating physician. However, the Appellate court concluded that the trial court did not abuse its discretion in any of the evidentiary rulings and that trial court verdict was supported by substantial evidence and is evidence and is not irreconcilable, and that the $ 8.3 million compensatory damages award is not so grossly out of proportion as to shock the conscience. Hence, the trial court judgement was affirmed. In this regard, we note the following observations of the Appellate Court.

(a) Kransky was one of many patients who experienced problems with an ASR XL implant. As early as 2006, surgeons began to observe an unusually high rate of problems with the ASR XL. These problems included "component loosening, component misalignment, infection, fracture of the bone, dislocation, metal sensitivity and pain." Data from national registries of hip implants around the world began reflecting higher than expected rates of revision (surgery to remove and replace the implant) for the ASR XL. Australia, one of the first countries where DePuy sold the ASR XL, showed a five-year revision rate of 22%, as did English and Welsh registries. DePuy's other metal-on-metal hip implants on the market at the time averaged five-year revision rates of approximately 4%. In 2010, when the failure rates of the ASR XL implant were widely known, DePuy voluntarily recalled the implant before the FDA took any action. On the recall form DePuy filed with the FDA, DePuy checked a box to indicate that the recall was the result of a "defective product that would affect product performance and/or could cause health problems.

(b) Although Kransky's physicians were concerned that he may not survive a revision surgery, they believed that the need to remove the implant outweighed the risks. In February 2012 an orthopaedic surgeon successfully performed the revision surgery, removing the ASR XL. The surgeon found classic symptoms of metal wear from a failed implant. A biomedical engineer analysed Kransky's ASR XL implant and found evidence of "much more than normal" metal wear on the implant. The engineer also found black-stained tissue attached to the back of the implant's cup. The engineer concluded that the ASR XL implant was defective because of excessive rim loading (the engineering term for when the head of the implant gets too close to the rim of the cup) that released a harmful amount of metal debris. After the surgery, Kransky's pain levels decreased and his mobility improved.

(c) Kransky filed a complaint asserting 13 causes of action against DePuy and others. By the time of trial, the only issues were against DePuy for negligent design, strict liability design defect, and strict liability failure to warn.

(d) To prove that the design process of the ASR XL had been inadequate and that the product was defective, Kransky called several witnesses, including the project manager in charge of developing the ASR XL implant. The project manager testified that he had never developed a hip implant before joining DePuy and he had no experience with orthopaedic devices before joining DePuy. A biomedical engineer testified that DePuy's testing technique and its decisions based on premarket testing fell short of acceptable industry standards. The engineer further testified that DePuy conducted a risk analysis that violated fundamental international consensus, downplayed the risks of the ASR XL's failure, and avoided fixing problems that would have prevented the implant's failure. He testified that DePuy violated the "rules of the road" of developing medical devices.

(e) Kransky also called witnesses knowledgeable about DePuy's business practices relating to the development and sale of the ASR XL. DePuy's worldwide vice president of marketing testified about the relative importance of profit and patient safety. The leader of the marketing team that introduced the ASR XL into the United States testified about what and when the marketing team knew about the release of metal ions into ASR XL patients. He also testified that DePuy recalled the ASR XL because it was not meeting their "clinical requirements" and the revision rate was unacceptably high.

(f) Kransky also introduced evidence of the ASR XL's high revision rate, and how its unique design characteristics caused a high level of wear and the release of toxic metal debris from the implant, which caused Kransky's injury. A toxic-chemicals specialist from the University of California, San Francisco testified that metal ions released by the implant were toxic and could cause tissue damage. A key engineer of the ASR XL also testified that metal ions from the ASR XL could cause tissue damage.

(g) Craig Swenson, an orthopaedic surgeon with extensive experience with the ASR XL implant, testified as an expert witness for Kransky. He showed the jury pictures from five other revision surgeries that he had performed on other patients with the ASR XL implant. He used these pictures and information about these surgeries to explain to the jury how he believed the ASR XL failed and how it showed signs of such a failure.

(h) The jury found DePuy strictly liable under applicable Montana law for a design defect in the ASR XL, but not for failure to warn. The jury also found that DePuy had been negligent, but that DePuy's negligence did not cause Kransky's injury. The jury awarded Kransky over $8.3 million in compensatory damages, consisting of $338,136.12 in economic damages and $8 million in past noneconomic damages. The jury did not find DePuy liable for punitive damages.

(i) The trial court did not abuse its discretion by excluding evidence of the FDA's clearance of the implant for sale in the United States.

(j) The trial court here similarly reasoned that evidence of the FDA's clearance of the implant was not relevant to, or had little probative value in, a Montana products liability design defect claim, characterizing the FDA evidence as "of marginal relevance," "of moderate, if any, relevance," and "irrelevant." Because evidence that a product meets certain agency standards is not relevant to the issue whether that product is defective under Montana law, the trial court correctly determined that the FDA evidence had little or no probative value in this case.

(k) Dr. Trotsky's opinion that the implant was the cause of Kransky's poor health, and that the implant was poisoning and killing Kransky, was admissible. "A treating physician is a percipient expert, but that does not mean that his testimony is limited only to personal observations.

(l) After performing 207 surgeries to implant the ASR XL, and 70 revision surgeries to remove the ASR XL, Dr. Swenson testified that he saw "trends" in his experience "taking care of this particular product." He testified that patients "start developing a local collection of [metal] ions and then [the hip] starts hurting and then they get this soft tissue mass that gets bigger and bigger and bigger and then to a varying degree it starts eating away soft tissue, muscle, bone and capsule. Their ion levels go up. We see them very frequently compared to other total hip[ replacement]s." Dr. Swenson used five case studies--information about patients on whom he had performed revision surgeries and pictures from those surgeries--to illustrate how the implant fails.

(m) Dr. Swenson testified that he "selected five patients that [he] thought were representative of the problems [he] saw with ASRs," in order to illustrate those problems. He testified that these patients, like Kransky, all had mechanical problems, pain, fibrous fluid collection, or high cobalt and chromium levels after he put in the ASR XL, and that they, like Kransky, all needed revision surgery to remove the implant. DePuy argues that Dr. Swenson's opinion testimony was inadmissible because "anecdotal accounts" are unreliable and improper bases for an expert opinion on causation.

(n) Substantial evidence supports the jury's finding that the implant's design defect caused Kransky's injury.

(o) Dr. John Dennis Bobyn, a professor and researcher in the field of artificial joint replacement at McGill University, testified that certain design features unique to the ASR XL caused increased wear. Dr. Bobyn examined Kransky's "explant" (the implant after Kransky's surgeon removed it from his hip) and testified that it was defective. Dr. Bobyn concluded Kransky's hip implant had worn excessively, "far beyond historical norms, far beyond expectations," which caused the implant to generate excessive amounts of cobalt and chromium.

(p) Robert Harrison, a toxic chemicals specialist who had treated patients with high cobalt and chromium levels from the ASR XL implant, testified that metal debris from a metal-on-metal hip implant like Kransky's implant causes "destruction, inflammation, pain and disability." He stated that cobalt and chromium "are most certainly poisonous" and "toxic," and that "when they get out into the blood, [they] can cause really severe local tissue damage around hips."

(q) Multiple witnesses testified that surgeons often insert implants at high angles, and that a patient's anatomical distinctions, rather than a surgeon's skill, primarily determine the angle at which implants are inserted. There was no evidence that inserting a hip implant at a high angle was misuse of the product or malpractice by a surgeon, and DePuy admitted in its interrogatory responses that it was not contending that the surgeon who implanted Kransky's ASR XL failed to follow warnings or instructions, or acted negligently when inserting the hip implant at a high angle.

(r) There is no inconsistency between the jury's findings of strict liability for design defect and no liability for failure to warn.

There is no inconsistency between the jury's causation findings.
Kransky's doctor testified that he explained to Kransky, "There's a good chance you will die if the hip is replaced." Kransky felt he "had no choice" but to have a surgery that would likely kill him: "I thought, 'Well, I'm going to die either way. One way is going to be fast. The other is going to be slow.'" He was so afraid that he would die during the revision surgery that he made funeral arrangements before the surgery. By the time he had the revision surgery; Kransky "had little spontaneous movement [and] was virtually inanimate." "My relationship with my wife, my kids, my grandkids," Kransky testified, "it was all gone."

22. The counsel for the OP submitted that these judgments are not between the parties and based upon its own evidence and as such are neither admissible not reliable. This argument is not liable to be accepted. This judgment relates to similar ASR XL hip implant, metal-on-metal, manufactured by DePuy at the same time, and as such, is relevant and admissible under Section 13 of Evidence Act, 1872 as held by Bombay High Court in Mohd. Amin Vs. Hasan, ILR 31 Bombay 143, Supreme Court in Bhagwati Prasad Shah Vs. Dulhin Rameshwari Kuer, AIR 1952 SC 72 and Tirumala Tirupati Devastanams Vs. K.M. Krishnaiah, (1998) 3 SCC 331.

23. The parties also relied upon various pieces of medical literature/Research Articles on the subject in support of their contentions. Important observations/Findings of some of these studies/articles are given in the succeeding paragraphs.

i. Neuropsychiatric symptoms following metal-on-metal implant failure with cobalt and chromium toxicity -Research Article- Green et al, BMC Psychiatry (2017) 17-33

(a) There were at least 31,171 metal-on-metal (MoM) hip implants in the UK between 2003 and 2011. Some of these were subject to failure and wide scale recalls and revisions followed. Method: The study was a presentation of ten cases (mean age 60 years) where they evaluated neuropsychiatric morbidity following metal-on-metal hip implant failure and revision. The study described neuropsychiatric complications after revision surgery where there has been cobalt and chromium toxicity. The results of study showed that Pre-revision surgery, nine patients had toxic levels of chromium and cobalt (mean level chromium 338 nmol/l, mean cobalt 669.4 nmol/l). Depression assessment showed 9 of 9 respondents fulfilled the BDI criteria for depression and 3 of these were being treated, 7 of 9 patients showing short term memory deficit with mean mini mental state examination score of 24.2. The normal population mean MMSE for this group would be expected to be 28 with <25 indicating possible dementia. In conclusions, the study found neurocognitive and depressive deficits after cobalt and chromium metallosis following MoM implant failure.

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(b) The study observed that after MoM hip resurfacing, higher cobalt and chromium concentrations in blood have been associated with structural changes in visual neurological pathways. There are reports of metallosis following MoM hip implant failure, but little is known about the specific impacts of chromium and cobalt metallosis from these implants. Neurological problems including changes in brain structure and function have been reported following MoM hip resurfacing and higher chromium/cobalt levels. Neurocognitive abnormalities however might be mediated by either static brain damage caused by chromium and cobalt toxicity or could represent a dynamic process, that is an early onset dementia triggered by metallosis. The study admits, that these findings, which are published for the first time, in a small study of sample of patients from a consecutive series of medicolegal referrals, which may have selection bias. This study was not founded by any third party.

ii. Heavy Metals and Epigenetic Alternations in Brain Tumours, by Maria Caffo et al -Current Genomics, 2014, 15, 457-463.

(a) Heavy metals and their derivatives can cause various diseases. Numerous studies have evaluated the possible link between exposure to heavy metals and various cancers. Recent data show a correlation between heavy metals and aberration of genetic and epigenetic patterns. From a literature search we noticed few experimental and epidemiological studies that evaluate a possible correlation between heavy metals and brain tumours.

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(b) Recent literature has evidenced cancer incidence, including gliomas, in subjects with prolonged exposure to heavy metals such as lead, nickel, chromium and cadmium. Carcinogenic metals can alter various cellular processes causing DNA damages with oxidative and non-oxidative mechanisms.

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(c) Recent evidences from epidemiological studies demonstrate that some neurological diseases, such as Alzheimer's and Parkinson's disease, may be correlated to heavy metals' exposure. Although the exact mechanisms are still unclear, new data suggest that metals cause oxidative stress, neuro-inflammation, and cellular death. The formation of radicals is increased in the brain because of the considerable oxygen metabolism of neurons.

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(d) Prolonged exposure to heavy metals such as lead, nickel, arsenic, and cadmium is strongly correlated with an increased likelihood of malignancy and, specifically, for brain tumours as well as of disorders of the cardiovascular system and the renal system, and cognitive impairment in children. From experimental data, it is evident that exposure to carcinogenic metals can be correlated to alterations in the epigenetic profile.

iii. ISHKS Joint Registry: A Preliminary Report- Jawahir A Pachore et al-Indian Journal of Orthopaedics -September 2013-Vol.47-Issue5

(a) Joint Replacement (arthroplasty) as a surgical option for end stage arthritis is well established now. Indian Society of Hip and Knee Surgeries (ISHKS) was established in 2005 with several goals.

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(b) Orthopaedic joints implants such as used for total knee arthroplasty (TKA) and total hip arthroplasty (THA) are normally expected to last for more than a decade based on clinical studies. New implants continue to be introduced with the hope that they are better than previous ones, but not all new prosthesis are better. In fact, some joint replacement implants that were thought to be the latest and better have turned out to be failures and even recalled. History of arthroplasty implants shows that many devices such as threaded acetabular shells, metal backed patellar components, first generation ceramic heads and titanium bearing surfaces all failed early. Recent examples include early failure of Sulzer acetabular cup and 3 M capital hip implant and ASR (Articular Surface Replacement. DePuy,USA) hip resurfacing system.

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(c) Total Hip Arthroplasty- Total of 3604 THA procedures were recorded. These included 2162 (60%) male patients and 1442 (40%) female patients. Average age was 52 years (Range 17 to 85 years) and average BMI was 25.8 (Range: 17.3 to 38.5).

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(d) Total of 261 Revision THA procedures were recorded.

iv. Out of Joint- The Story of the ASR -Dborah Cohen _BMJ 2011:342

(a) It is one of the biggest disasters in orthopaedic history, according to one senior surgeon. On 24 August 2010, DePuy, a subsidiary of American giant Johnson and Johnson, recalled its ASR (articular surface replacement) hip prostheses from the market. The recall followed years of denial by the company that the ASR implants had caused pain and disability in patients. In a statement to the BMJ, DePuy claim that "given the available information, we believe we made the appropriate decision to recall at the appropriate time."

(b) Pathologically, the failing prosthesis had several effects. Metal debris from wear of the implant led to a reaction that destroyed the soft tissues surrounding the joint, leaving some patients with long term disability. Ions of cobalt and chromium-the metals from which the implant was made- were also released into the blood and cerebral spinal fluid in some patients.

(c) The long term effects are uncertain. But the US Food and Drug Administration recommends that patients should be monitored for systemic effects, particularly cardiovascular, neurological, renal, and thyroid signs and symptoms.

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(d) The ASR is a "metal on metal" hip- the head at the top and the lining of the cup it fits into are made of cobalt chrome metal rather than ceramic or polyethylene. The devices come in different sizes according to the existing anatomy and there are forms for both total hip replacement (ASR XL) and hip resurfacing (ASR resurfacing).

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(e) The UK Medicines and Healthcare Products Regulatory Agency (MHRA) says that clinical studies may be too small and short to detect problems for premarket approval purposes. But clinical tests with relatively short follow-up may have picked up problems with the ASR.

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(f) The absence of any clinical studies of implants in patients before approval remains a cause for concern-much like it was over 10 years ago with the 3M Capital hip.

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(g) Although the ASR resurfacing made it onto the European market, it was not approved in the US. Resurfacing was a new technique and so the implant had to go through the FDA's more rigorous premarket approval process. This requires manufacturers to submit their product to clinical testing to prove it is both safe and- unlike the European process-effective for its intended use. The FDA asked DePuy to perform a clinical study called an investigational device exemption (IDE).

Tony Nargol, an orthopaedic surgeon at the University Hospital of North Tees, was one of the surgeons involved in the studies for the American market. But not everything was going to plan. As internal DePuy emails show, he reported problems with fractures in some of his patients. The FDA sent detailed questions to the company.

"You have not provided any explanation why this experienced investigator may have had a higher femoral neck fracture rate in this IDE study. It is concerning that an experienced surgeon who is familiar with patient selection criteria and surgical technique would have the highest neck fracture rate," it said. So problems were being picked up in the premarket clinical study-despite some insisting that these studies are too small for this purpose. Surgeons experienced in the resurfacing technique should not have a fracture rate of more than 1% a year.

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(h) Although the FDA's premarketing approval process requiring a clinical study may have protected patients from the widespread uptake of the failing ASR resurfacing prosthesis, the same could not be said about ASR XL, the total hip replacement. This passed through the FDA's 510(k) clearance process via the "similar equivalence" route, whereby companies need only to show that their product is similar to something else on the market. Even a small change in design can have a substantial effect on long term outcome.

Critics say that the similar equivalence route is not nearly stringent enough. Yet this is how 90% of devices gain US approval. Companies say that toughening up the approval process will be bad for patients-they will be denied access to new improved technologies that are available elsewhere.

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(i) A few years later, Mr Nargol started to notice problems with the ASR. In early 2007, some of his patients reported groin pain and difficulty walking. He got a shock when he opened them up to revise their prostheses. The soft tissues and muscles around the hip were destroyed. He noticed a pus-like fluid coming from the capsule. Initially he put it down to infection. But cultures were negative. And then we went on to find cases where the bone was starting to get destroyed as well. Mr. Nargol said.

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He raised his concerns with the company, and asked whether anyone else was having problems. As internal emails show, company managers hoped to pass this off as a failure of surgical technique-even though he was an experienced resurfacing surgeon.

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(j) By 2007, individual surgeons were not the only people noticing problems. The Australian National Joint Replacement Registry reported that the ASR had a high revision rate. The registry was set up to spot "outliers"-prostheses that have twice the rate of revision of others in their class. All hip prostheses fail in some patients, but it is expected that the rate will be about 1% a year. The Australian data showed a 5.16% (95% confidence interval 3.50% to 7.56%) revision rate at two years.

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According to a presentation Professor Graves gave at a meeting in Glasgow, the Australian joint registry warned the Australian regulators and DePuy 17 times about problems with the ASR between 2007 and 2009.

But, according to internal company documents, concerns were explained away and sales representatives were instructed to keep on marketing the product. To counter the Australian registry's findings, internal documents show that DePuy sent out a "white paper" by one of the ASR design surgeons. Professor Vail, explaining how to interpret the Australian data.

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(k) But in the end, DePuy "voluntarily recalled" the ASR in August 2010, saying the recall was due to unpublished NJR data showing a 12% revision rate for resurfacing at five years and an ASR XL revision rate of 13%. "Early revision of poorly performing hip replacements that generate metal debris should give a better revision outcome", it added on the field safely notice-the means by which manufacturers alert people that a product is being recalled.

But revision of a destroyed joint is not straightforward. Not only are patients put at anaesthetic risk once again, the revisions have a higher risk of failure."

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

There is widespread concern regarding the incidence of adverse soft-tissue reactions after metal-on-metal (MoM) hip replacement. Recent National Joint Registry data have shown clear differences in the rates of failure of different designs of hip resurfacing. Our aim was to update the failure rates related to metal debris for the Articular Surface Replacement (ASR). A total of 505 of these were implanted.

Kaplan-Meier analysis showed a failure rate of 25% at six years for the ASR resurfacing and of 48.8% for the ASR total hip replacement (THR). Of 257 patients with a minimum follow-up of two years, 67 (26.1%) had a serum cobalt concentration which was greater than 7 µg/l. Co-ordinate measuring machine analysis of revised components showed that all patients suffering adverse tissue reactions in the resurfacing group had abnormal wear of the bearing surfaces. Six THR patients had relatively low rates of articular wear, but were found to have considerable damage at the trunion-taper interface. Our results suggest that wear at the modular junction is an important factor in the development of adverse tissue reactions after implantation of a large-diameter MoM THR.

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.

(a) Articular Surface Replacement (ASR) hip prostheses, which have metal-on-metal bearing surfaces, were manufactured by DePuy Orthopaedics (Warsaw, Indiana) for use in both conventional total hip anthroplasty and hip resurfacing. Both the ASR XL Acetabular System and the ASR Hip Resurfacing System were recently recalled worldwide by the manufacturer. This report summarizes an analysis by the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) of the outcome of arthroplasties involving the ASR prostheses.

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(b) Arthroplasties involving both designs had a significantly greater revision rate compared with those involving all other prostheses. The cumulative revision rate of arthroplasties involving the ASR XL Acetabular System at five years postoperatively was 9.3% (95% confidence interval [C1],7.3% to 11.9%) compared with 3.4% (95% Cl, 3.3% to 3.5%) for total hip arthroplasties involving all other conventional prostheses. The cumulative revision rate of arthroplasties involving the ASR Hip Resurfacing System at five years postoperatively was 10.9% (95% CI, 8.7% to 13.6%) compared with 4.0% (95% CI, 3.7% to 4.5%) for arthroplasties involving all other resurfacing prostheses. Arthroplasties involving the ASR XL Acetabular System had a greater rate of revision due to implant loosening and/or osteolysis and due to metal sensitivity compared with total hip arthroplasties involving all other conventional prostheses. Arthroplasties involving the ASR XL Acetabular System also had a significantly greater revision rate compared with total hip arthroplasties involving all other conventional metal-on-metal prostheses. Arthroplasties involving the ASR Hip Resurfacing System had a greater rate of revision due to metal sensitivity compared with total hip arthroplasties involving all other resurfacing prostheses.

ASR prostheses used in conventional hip arthroplasty and in hip resurfacing exhibited a greater revision rate compared with other prostheses in the AOANJRR. These results are consistent with those derived from other registries and from published studies of individual cohorts.

vi. 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)

(a) Take-Home Points

High rate of failure of DePuy Synthes ASR XL Acetabular hip system used in THA, approaching 34.4% at 5 years.
Mean time to revision was 3.1 years with pain being the most common indication for revision surgery.
Age, gender, acetabular component abduction angle, acetabular size, and serum cobalt or chromium levels were not associated with increased rate of failure,
Serum cobalt and chromium levels decreased significantly within 6 months of revision surgery.
Close clinical surveillance and laboratory monitoring of patients is required.

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(b) The articular surface replacement (ASR) acetabular system (DePuy Synthes) was approved for sale by the US Food and Drug Administration in 2003 and implanted in an estimated 93,000 cases. Since then, however, the early failure rate of the prosthesis has been well documented, leading to a formal global product recall in August 2010. The Australian Orthopaedic formal global product recall in August 2010. The Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) was amongst the first to report a 6.4% rate of failure of the device at 3 years when inserted with a Corail stem. An acceptable upper rate of hip prosthesis failure is considered to reach 1% per year, with the majority of implants reporting well below this value. A 10.9% failure rate at 5 years was documented when the prosthesis was inserted for resurfacing. The National Joint Registry of England and Wales confirmed these findings and observed a 13% and 12% rate of failure at 5 years for the acetabular and resurfacing systems, respectively. With the notable failure of the ASR system, this study reports our single-center 5-year survivorship experience and evaluates any variable that might be predictive of an early failure to aid in patient counselling.

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(c ) No implant failures were noted in the first year, The 5-year revision rate reached 34.4% (10 patients with 11 hip replacements). Mean time to revision for this subgroup was 3.1 years. Overall, an implant failure was observed in 37.5% of patients (11 patients with 12 hip replacements) at a mean postoperative follow-up of 6.2 years.

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(d) Considerable controversy surrounds the causes of adverse wear failure in MoM bearings. The non-modular design of the ASK prostheses is frequently implicated as a cause of early failure. The lack of a central hole in the 1-piece component compromises the tactile feel of insertion, thereby reducing the surgeon's ability to assess complete seating. This condition may potentially increase the abduction angle at the time of insertion. Screw fixation of the non-modular device is not possible. The ASR XL device (148' to 160') is less than a hemisphere (180') in size and hence features a diminished functional articular surface, further compromising implant fixation. The functional articular surface is defined as the optimal surface area (10 mm) needed for a MoM implant. Griffin and colleagues reported a 48 mm ASR XL component, when implanted at 45' of abduction, to function similar to an implant at 59' of abduction, leading to diminished lubrication, metallosis, and edge loading. The version of the acetabular component may similarly and adversely affect implant wear characteristics. Furthermore, the variable thickness of the implant, which is thicker at the dome and thinner at the rim, may further promote edge loading by shifting the center of rotation of the femoral head out from the center of the acetabular prosthesis. Studies have also shown that increased wear of the MoM articulation is associated with an acetabular component inclination angle in excess of 55' and a failure of fixation at time of implantation. This study, however, found no correlation between the abduction angle and risk of early implant failure for the ASR acetabular component. No correlation was also detected between the acetabulum size and revision surgery.

The AOANJRR reported loosening (44%), infection (20%), metal sensitivity (12%), fracture (9%), and dislocation of prosthesis (7%) as the indications for revision surgery for the ASR prosthesis. Furthermore, a single-center retrospective review of 70 consecutive MoM THAs with ultra-large diameter femoral head and monoblock acetabular components showed that 17.1% required revision within 3 years for loosening, pain, and squeaking. Overall, 28.6% of patients reported implant dysfunction. In this study, we observed a similar rate of failure at 3 years (15.6%) for pain (11) and infection (1). The revision surgery successfully relieved all of these symptoms. One patient presented with heterotopic ossification and anterior hip pain after the original revision and required additional surgery with prosthesis retention. No patient in this series required repeat component revisions at a mean of 2.9 years after surgery. In all but 1 case, primary acetabular components were used in the revision, and in all cases except that with infection, the femoral component was retained. Replacement shells were 2 to 4 mm larger in diameter than the original ASR component.

Recently, concerns have arisen regarding the long-term effects of serum cobalt and chromium metal ions levels. Studies have shown increased serum metal ion levels, groin pain, pseudotumor formation, and metallosis after the implantation of MoM bearings. In a case study by Mao and colleagues, 1 patient reported headaches, anorexia, continuous metallic taste in her mouth, and weight loss. A cerebrospinal fluid analysis revealed cobalt and chromium levels at 9 and 13 nmol/L, respectively, indicating that these metal ions can cross the blood-brain barrier. Another patient reported painful muscle fatigue, night cramps, fainting spells, cognitive decline, and an inability to climb stairs. His serum cobalt level reached 258 nmol/L (reference range, 0-20 nmol/L), and chromium level totaled 88 nmol/L (reference range, 0-100 nmol/L). At 8-week follow-up after revision surgery, the symptoms of the patient had resolved, with serum cobalt levels dropping to 42 nmol/L. None of the patients in this study presented with any signs or symptoms of metal toxicity. The upper limits of blood cobalt and chromium levels in our study population reached 18.9 and 15.9 µg/L for the revised group and 16.8 and 5.4 µg/L for the non-revised group, respectively. However, we noted a similar drop in post-revision blood cobalt (91% decrease) and chromium (78% decrease) levels.

In summary, our data showed a high revision rate of the DePuy Synthes ASR XL Acetabular hip system. Our findings are consistent with internationally published data. In the absence of reliable predictors of early failure, continued close clinical surveillance and laboratory monitoring of these patients are warranted.

Conclusion -This study demonstrates the high failure rate of the DePuy Synthes ASRT XL Acetabular hip system used in THA at a minimum of 5 years of follow-up. No variable that was predictive of failure could be identified in this series. Close clinical surveillance of these patients is therefore required. Metal levels dropped quickly after revision, and the revision surgery can generally be performed with slightly larger primary components. Symptomatic patients with ASR hip replacements, regardless of blood metal-ion levels, were candidates for the revision surgery. Not all failed hips exhibited substantially elevated metal levels. Asymptomatic patients with high blood metal-ion levels should be closely followed-up and revision surgery should be strongly considered, consistent with recently published guidelines.

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

Purpose: The development of persistent postoperative pain may occur following surgery, including total hip replacement. Yet, the prevalence may depend on the definition of persistent pain. This observational cohort study explored whether the prevalence of persistent pain after total hip replacement differs depending on the definition of persistent pain and evaluated the impact of ongoing pain on the patient's quality of life 6 months after surgery.

Patients and methods: Pre- and postoperative characteristics of 125 patients undergoing elective total hip replacement were assessed and 104 patients were available for the follow-up interview, 6 months after surgery.

Results: Six months after surgery, between 26% and 58% of patients still reported hip pain - depending on the definition of persistent pain. Patients with moderate-to-severe persistent pain intensity (>3 on a numerical rating scale) were more restricted in their daily life activities (Chronic Pain Grade - disability score) but did not differ in reported quality of life (Short-Form 12) from those with no pain or milder pain intensity. Maximal preoperative pain intensity and body mass index were the only independent factors influencing daily function 6 months after total hip replacement.

Conclusion: These findings support a high prevalence of persistent postoperative pain after total hip replacement and a large variability depending on the definition used. There was a close relation between physical functioning and pain as well as relevance of the patient's psychological state at the time of the operation.

ix. A review of the health hazards posed by cobalt-Dennis J. Paustenbach et al -Review Articles- http://informahealthcare.com/txc

Cobalt (Co) Is an essential element with ubiquitous dietary exposure and possible incremental exposure due to dietary supplements, occupation and medical devices. Adverse health effects, such as cardiomyopathy and vision or hearing Impairment, were reported at peak blood Co concentrations typically over 700 µg/L (8-40 weeks), while reversible hypothyroidism and polycythemia were reported in humans at -300 µg/L and higher (≥2 weeks). Lung cancer risks associated with certain inhalation exposures have not been observed following Co ingestion and Co alloy implants. The mode of action for systemic toxicity relates directly to free Co(II) ion interactions with various receptors, ion channels and biomolecules resulting in generally reversible effects. Certain dose-response anomalies for Co toxicity likely relate to rare disease states known to reduce systemic Co(II)-ion binding to blood proteins. Based on the available information, most people with clearly elevated serum Co, like supplement users and hip implant patients, have >90% of Co as albumin-bound, with considerable excess binding capacity to sequester Co(ll) ions. This paper reviews the scientific literature regarding the chemistry, pharmacokinetics and systemic toxicology of Co, and the likely role of free Co(II) ions to explain dose-response relationships. Based on currently available data, it might be useful to monitor implant patients for signs of hypothyroidism and polycythemia starting at blood or serum Co concentrations above 100 µg/L. This concentration is derived by applying an uncertainty factor of 3 to the 300 µg/L point of departure and this should adequately account for the fact that persons in the various studies were exposed for less than one year. A higher uncertainty factor could be warranted but Co has a relatively fast elimination, and many of the populations studied were of children and those with kidney problems. Closer follow-up of patients who also exhibit chronic disease states leading to clinically important hypoalbuminemia and/or severe ischemia modified albumin (IMA) elevations should be considered.
Cobalt (Co) is a component of cyanocobalamin, an essential vitamin (vitamin B-12) that is required for the production of red blood cells (RBCs) and the prevention of pernicious anaemia (Barceloux, 1999). Due to its ability to stimulate haemoglobin and RBC production, Co was historically used to treat certain types of anaemia (Stokinger, 1962).
Drinking water infrequently contains Co at concentrations of 0.1-5 µg/L, with surface waters and coastal seawater more commonly containing detectable levels because of transport of dissolved Co that is bound to natural organic substances.
We believe the existing clinical data provide evidence of little to no-risk of Co-related systemic health risk in patients with well-functioning implants. Specifically, a vast majority of the published blood Co concentrations in hip implant patients are below 10µg/L.
To our knowledge, there have been no reports that clearly support Co-related health effects occurring in patients with well functioning implants and lower blood Co concentrations (e.g., <10µg/L).

x. Cobalt toxicity in humans. A review of the potential sources and systemic health effects-Laura Leyssens et al- Unpublished Manuscript

Abstract- Cobalt (Co) and its compounds are widely distributed in nature and are part of numerous anthropogenic activities. Although cobalt has a biologically necessary role as metal constituent of vitamin B12, excessive exposure has been shown to induce various adverse health effects. This review provides an extended overview of the possible Co sources and related intake routes, the detection and quantification methods for Co intake and the interpretation thereof, and the reported health effects. The Co sources were allocated in four exposure settings: occupational, environmental, dietary and medical exposure. Oral intake of Co supplements and internal exposure through metal-on-metal (MoM) hip implants, deliver the highest systemic Co. concentrations. The systemic health effects are characterized by a complex clinical syndrome, mainly including neurological (e.g. hearing and visual impairment), cardiovascular and endocrine deficits. Recently, a bio-kinetic model has been proposed to characterize the dose-response relationship and effects of chronic exposure. According to the model, health effects are unlikely to occur at blood Co concentrations under 300 µg/l (100 µg/l respecting a safety factor of 3) in healthy individuals, haematological and endocrine dysfunctions are the primary health endpoints, and chronic exposure to acceptable doses is not expected to pose considerable health hazards. However, toxic reactions at lower doses have been described in several cases of malfunctioning MoM hip implants, which may be explained by certain underlying pathologies that increase the individual susceptibility for Co-induced systemic toxicity. This may be associated with a decrease in Co bound to serum proteins and an increase in free ionic Co. As the latter is believed to be the primary toxic form, monitoring of the free fraction of Co might be advisable for future risk assessment. Furthermore, future research should focus of longitudinal studies in the clinical setting of MoM hip implant patients to further elucidate the dose-response discrepancies.

xi. Interpreting cobalt blood concentrations in hip implant patients- Dennis J. Paustenbach et al- Clinical Toxicology (2014), 52, 98-112

Introduction- There has been some recent concern regarding possible systemic health effects resulting from elevated blood cobalt concentrations in patients with cobalt containing hip implants. To date there are no blood cobalt criteria to help guide physicians when evaluating an individual hip implant patient's risk of developing systemic health effects because historically there was little or no concern about systemic cobalt toxicity in implant patients. Objective-Our purpose is to describe recently completed research regarding the relationship between blood cobalt concentrations and clinical health effects. We discuss the possibility of systemic health effects in patients with metal containing implants and propose various blood cobalt concentrations that are not associated with an increased risk of developing certain adverse effects Methodology- The primary literature search was conducted using PubMed and Web of Science using the following search terms: cobalt AND (toxicity OR health effects OR cardio-toxicity OR haematological OR endocrine OR immunological OR reproductive OR testicular effects OR neurological OR case report OR cobert OR Rencovite). The searches identified 6786 papers of which 122 were considered relevant. The Agency for Toxic Substances and Disease Registry taxicological profile for cobalt and the U.S. Environmental Protection Agency Office of Research and Development's National Center for Environmental Assessment's documentation on the provisional peer-reviewed toxicity value for cobalt were also utilized to identify secondary literature sources. Results- Our review of the toxicology and medical literature indicates that highly elevated blood cobalt concentrations can result in certain endocrine, haematological, cardiovascular, and neurological effects in animals and/or humans. These studies, in addition to historical clinical findings involving the therapeutic use of cobalt, indicate that significant systemic effects of cobalt will not occur below blood cobalt concentrations of 300 µg/L in most persons. Some individuals with specific risk factors for increased susceptibility (e.g., severe and sustained hypoalbuminemia) may exhibit systemic effects at lower cobalt blood concentrations. This review also describes several cobalt dosing studies performed with human volunteers that consumed cobalt for 15, 30, or 90 days. Overall, the results of these dosing studies indicate that sustained blood cobalt concentrations averaging 10-70 µg/L for up to 90 days cause no significant clinical effects (maximum concentrations approached 120 µg/L). Some proposed blood criteria for assessing implant wear and local tissue damage have been suggested by several medical groups. For example, the UK Medicines and Healthcare Products Regulatory Agency has proposed a blood cobalt guidance value of 7 µg/L, and the Mayo Clinic has suggested serum cobalt concentrations greater than 10 µg/L., but both of these values are primarily intended to address implant wear and to alert physicians to the possibility of an increased incidence of local effects. There is a clear lack of consensus regarding how to identify a specific numerical blood concentration of concern and whether whole blood or serum is a better matrix to assess total cobalt concentration. Conclusions- Based on currently available data, only under very unusual circumstances should a clinician expect that biologically important systemic adverse effects might occur in implant patients with blood cobalt concentrations less than 300 µg/L. Patients with metal-containing hip implants who exhibit signs or symptoms potentially related to polycythemia, hypothyroidism, neurological, or cardiac dysfunction should be clinically evaluated for these conditions. Polycythemia appears to be the most sensitive endpoint.

xii. Chromium as an Essential Nutrient for Humans- Richard A. Anderson- REGULATORY TOXICOLOGY AND PHARMACOLOGY 26, S35-S41 (1997) ARTICLE NO.RT 971136

Chromium is an essential nutrient required for sugar and fat metabolism. Normal dietary intake of Cr for humans is suboptimal. The estimated safe and adequate daily dietary intake for Cr is 50 to 200 µg. However, most diets contain less than 60% of the minimum suggested intake of 50 µg. Insufficient dietary intake of Cr leads to signs and symptoms that are similar to those observed for diabetes and cardiovascular diseases. Supplemental Cr given to people with impaired glucose tolerance or diabetes leads to improved blood glucose, insulin, and lipid variables. Chromium has also been shown to improve lean body mass in humans and swine. Response to Cr is dependent upon form and amount of supplemental Cr. Chromium is a nutrient; therefore, it will only be of benefit to those who are marginally or overtly Cr deficient. Trivalent Cr has a very large safety range and there have been no documented signs of Cr toxicity in any of the nutritional studies at levels up to 1 mg per day.

xiii. Depression and somatisation influence the outcome of total hip replacement-Wolfgang Riediger et al - International Orthopaedics (SICOT) (2010) 34:13-18

Abstract -Depression, somatisation and pain beliefs influence outcome of several painful musculoskeletal disorders. Their influence on the postoperative outcome of total hip replacement was investigated. A total of 79 patients who underwent primary total hip replacement completed questionnaires preoperatively and six weeks postoperatively addressing depression (Hospital Anxiety and Depression Scale-German version), pain beliefs (Pain Beliefs Questionnaire) and somatisation (Screening of Somatoform Disorders-2) as well as outcome [Western Ontario McMaster Universities Osteoarthritis Index (WOMAC), Medical Outcomes Study 36-Item Short Form (SF-36)]. Depressive patients showed a median preoperative WOMAC sum score of 30 compared to 45 in other patients and a postoperative score of 72 compared to 85, and patients with somatoform disorder of 32 compared to 46 preoperatively and 73 versus 86 postoperatively. Patients with high somatisation and depression scores feel worse in their hips and in general well-being before and surgery, but they experienced the same benefit from total hip replacement as those with low scores.

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.plosone.org.

Abstract -

Background: By measuring very early changes in muscle strength and functional performance after fast-track total hip arthroplasty (THA), post-operative rehabilitation, introduced soon after surgery, can be designed to specifically target identified deficits.

Objective(s): Firstly, to quantify changes (compared to pre-operative values) in hip muscle strength, leg-press power, and functional performance in the first week after THA, and secondly, to explore relationships between the muscle strength changes, and changes in hip pain, systemic inflammation, and thigh swelling.

Design: Prospective, cohort study.

Setting: Convenience sample of patients receiving a THA at Copenhagen University Hospital, Hvidovre, Denmark, between March and December 2011.

Participants: Thirty-five patients (65.9±7.2 years) undergoing THA.

Main outcome measures: Hip muscle strength, leg-press power, performance-based function, and self-reported disability were determined prior to, and 2 and 8 days after, THA (Day 2 and 8, respectively). Hip pain, thigh swelling, and C-Reactive Protein were also determined.

Results: Five patients were lost to follow-up. Hip muscle strength and leg press power were substantially reduced at Day 2 (range of reductions: 41-58%, P<0.001), but less pronounced at Day 8 (range of reductions: 23-31%, P<0.017). Self- reported symptoms and function (HOOS: Pain, Symptoms, and ADL) improved at Day 8 (P<0.014). Changes in hip pain, C- Reactive Protein, and thigh swelling were not related to the muscle strength and power losses.

Conclusion(s): Hip muscle strength and leg-press power decreased substantially in the first week after THA - especially at Day 2 - with some recovery at Day 8. The muscle strength loss and power loss were not related to changes in hip pain, systemic inflammation, or thigh swelling. In contrast, self-reported symptoms and function improved. These data on surgery-induced changes in muscle strength may help design impairment-directed, post-operative rehabilitation to be introduced soon after surgery.

xv. The Mechanism of Metallosis After Total Hip Arthroplasty-Chinedu C. Ude et al- Regenerative Engineering Translational Medicine (2021) 7:247-261.

Abstract - Metallosis is defined as the accumulation and deposition of metallic particles secondary to abnormal wear from prosthetic implants that may be visualized as abnormal macroscopic staining of periprosthetic soft tissues. This phenomenon occurs secondary to the release of metal ions and particles from metal-on-metal hip implants in patients with end-stage osteoarthritis. lons and particles shed from implants can lead to local inflammation of surrounding tissue and less commonly, very rare systemic manifestations may occur in various organ systems. With the incidence of total hip arthroplasty increasing as well as rates of revisions due to prosthesis failure from previous metal-on-metal implants, metallosis has become an important area of research. Bodily fluids are electrochemically active and react with biomedical implants. Particles, especially cobalt and chromium, are released from implants as they abrade against one another into the surrounding tissues. The body's normal defense mechanism becomes activated, which can elicit a cascade of events, leading to inflammation of the immediate surrounding tissues and eventually implant failure. In this review, various mechanisms of metallosis are explored. Focus was placed on the atomic and molecular makeup of medical implants, the component/surgical associated factors, cellular responses, wear, tribocorrosion, joint loading, and fluid pressure associated with implantation. Current treatment guidelines for failed implants include revision surgery. An alternative treatment could be chelation therapy, which may drive future studies.

Lay Summary- Arthroplasty is an invasive procedure which disrupts surrounding joint tissues, and can greatly perturb the joint's immune homeostasis. In some instances, this may pose a difficult challenge to implant integration. Particles released from implants into the surrounding joint tissues activate the body's defense mechanism, eliciting a cascade of events, which leads biotribocorrosion and electrochemical attacks on the implant. This process may lead to the release of even more particles. Besides, implant makeup and designs, frictions between bearing surfaces, corrosion of non-moving parts with modular junctions, surgical mistakes, patient factor, comorbidities, and loosened components can alter the expected function of implants. High accumulations of these ions and particulates result in metallosis, with accompanying adverse complications. Current recommended treatment for failed prosthesis is revision surgeries. However, chelation therapy as a prophylactic intervention may be useful in future efforts but more investigation is required.

24. The complainant was 52 years old at the time of first surgery on 02.04.2009. Total right hip replacement surgery of the complainant was done on 02.04.2009 and ASR XL hip implant was placed. The complainant stated that due to serious discomfort, the complainant again visited the hospital on 29.11.2010 then OP-5 asked her to register on the helpline of OP-1 to 3 and she got registered in November, 2013, who obtained blood test report, X-ray and MRI from their consultant in Mumbai. In blood test report dated 14.12.2013 cobalt level was 1.78 and chromium <0.5 ug/l as against normal level of 0.70 - 28.00 were found. According to OP-1 no symptom was found requiring revision surgery as such the complainant was not recommended for revision surgery at that time. The complainant stated that her X-ray and MRI of right hip and lateral and blood test report revealed (i) Reduced bone density with preserved texture; (ii) Residual osteoarthritis changes with geode formation, where regression in size noted as compared to old X-ray. Reduction in bone thickness noted of acetabular roof centrally; (iii) Severe atrophy of the right piriformis indicating severe pain in buttock; (iv) Moderate atrophy of the gluteus minimus, medius and maximus indicating degeneration of hip muscles; (v) Fragments of bone debris; (vi) Alarming low level chromium <0.5 ug/l as against normal level of 0.70 - 28.00. Due to persistent progressive pain, limp while walking, limitations of movements and difficulties in day to day activities, the complainant consulted with various orthopaedic doctors for persistent pain, namely Prof (Dr.) Suraj Bhan on 29.11.2013 (previously also on 06.09.2011), Dr. Anil Saxena at Gwalior on 17.01.2014, Dr. Somnath Bani at Bombay on 03.02.2014, Dr. Surendra Nath at Hyderabad on 03.03.2014, Dr. Gaurav Bhardwaj on 26.05.2014 and 30.07.2014, who advised for revision surgery and pain killers. Radiological reports conducted on the advice of above doctors gave findings that (i) severe muscle atrophy of the right piriformis with moderate atrophy of gluteus minimus, medius and maximus; (ii) Hetrophic ossification/calcification along the superiolateral aspect of the joint; (iii) Definite hint of protrusion in right acetabular space; and (iv) Degenerative changes noted in the right hip joint in the form subchondral cyst formation, sclerosis. Right lower limb shortening 1 cm was noted. "Secondary osteoarthritis right hip" was diagnosed. In report dated 18.12.2013, calcification was noted along the superolateral aspect of the joint. In the report dated 27.07.2014, degenerative changes in right hip joint in the form of subchondral cyst formation, sclerosis were noted. Impression was osteoarthritis changes. The revision surgery was done on 23.08.2021.

25. U.S. Food and Drug Administration warned the patients in its country who had metal-on-metal implants, should be aware of potential symptoms which may occur after surgery and indicate that their device is not functioning properly. Common symptoms may include: Pain in the groin; swelling at or near the hip joint; and a limb or change in walking ability. U.S. Food and Drug Administration clearly mentioned that there was no way to fully avoid the production of metal particles in metal-on-metal implants. The metal particles around some implants can cause damage to bone and/or tissue surrounding the implant joint which is sometime referred to as an "adverse local tissue reaction" (ALTR) or an "adverse reaction to metal debris" (ARMD). Such a reaction may cause the implant to become loose or cause pain. High levels of metal ions in the bloodstream in some patients may cause other types of symptoms or illnesses, including effects on the heart, nervous system and thyroid glands. As soon as DePuy received unpublished data in July 2010, from National Registry of England & Wales suggesting that five-year revision rate for ASR Resurfacing System was approximately 12% and that for the ASR XL Acetabular system was approximately 13% across the entire size range and further that the revision rate was highest with ASR head sizes below 50 mm in diameter and among female patients, the DePuy Medical Private Limited voluntarily recalled the entire range of ASR Hip Implants globally including from the Indian market vide their letter dated 24.08.2010 but denies that recall was due to any defect. California Court found that the ASR XL implant was defective because of excessive rim loading (the engineering term for when the head of the implant gets too close to the rim of the cup) that released a harmful amount of metal debris, which was poisonous. In remedial measure adopted by the OP directed for the evaluation the blood test for examining the level of microscopic metal particles around your hip. In letter dated 24.08.2010, the OP mentioned reasons for revision identified within the datasets were consistent with previously reported for ASR and include component loosening, component malignant, infection, fracture of the bone, dislocation, metal sensitivity and pain. If these reasons are co-related with the remedial measure and the instruction of U.S. Food and Drug Administration, then there appear no other conclusion except that metal-on-metal implant was creating metal debris at the joint, which was root cause for component loosening, component malignant, infection, fracture of the bone, dislocation, metal sensitivity and pain, in at least 13% patient and mostly in females. In view of aforesaid evidence, we found that ASR hip implants, metal-on-metal manufactured by the OP suffer from inherent manufacturing defect and released a harmful amount of metal debris, which was poisonous.

26. The counsel for the OP submitted that in case of sale of defective goods, Section 14(1)(d) of the Consumer Protection Act, 1986 provides for removal of the defect or at the most an order for replacement of the defective goods can be passed. In the present case, the OP has already reimbursed the expenses of revision surgery. Although in the complaint, alleging defect in goods, no compensation could be awarded but the OP voluntarily paid Rs.25/- lacs also as compensation as such no further relief can be granted. He further submitted that even in case of deficiency in service, loss occurred to the complainant due to deficiency in service has to be proved by documentary/oral evidence. The OP relied upon the judgment of 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 Tomar Vs. Dana Chogas Kitchen, 2016 SCC OnLine NCDRC 90 and Preeti Sharma Vs. Yashoda Super Speciality Hospital, 2019 SCC OnLine NCDRC 1099.

27. This argument is not liable to be accepted. When defective goods caused bodily injury then the compensation has to be awarded under the law of torts for such injury also. Supreme Court in Divisional Controller, KSRTC v. Mahadeva Shetty, (2003) 7 SCC 197, held as follows:-

"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 v. 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 v. 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 provisions clearly indicate 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 calculations. 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 v. Maharashtra SRTC AIR 1998 SC 3191.

16. This Court in R.D. Hattangadi v. Pest Control (India) (P) Ltd. [(1995) 1 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."

28. The complainant has claimed Rs.588000/- towards costs of medical attendance, Rs.15000000/- as compensation for physical shock, agony, pain and suffering, Rs.2500000/- as compensation for causing perpetual disability, Rs.5000000/- as compensation for internal bodily injury, which is neither identifiable nor curable, Rs.2500000/- as compensation for loss of expectation of life due to medical complication such as metal poisoning, damage to central nervous system, risk of cancer, osteolysis etc. and Rs.10000000/- as compensation for inconvenience, hardship, discomfort, frustration, disappointment, emotional distress and mental stress;.

29. At the time of first surgery, the age of the complainant was 52 years. The complainant has not produced reliable evidence to assess loss of income, medical expenses etc. Supreme Court in Civil Appeal No.1540 of 2022 Benson George Vs. Reliance General Insurance Company Limited (decided on 25.02.2022) awarded Rs.1000000/- as compensation for pain and suffering to a patient who was in coma for period of eight years. We think it proper that apart from the compensation offered by the OP, the complainant is entitled to Rs.1000000/- towards pain and suffering. The OP is giving Rs.25/- lacs to the patient, who have undergone for revision surgery and also reimbursing the expenses of revision surgery.

30. So far as allegation against the Drug Controller General of India is concerned, the relation of the complainant with OP-8 as "Consumer" and "service provider" is not proved. Drug Controller General of India has granted registration certificate and import licence in discharge of statutory duty under Drugs and Cosmetics Act, 1940. Supreme Court in Secretary, Ministry of Commerce and Ors. Vs. Vinod & Company, (2019) 19 SCC 427 held that such a function is not within the jurisdiction of consumer legislation. We have no jurisdiction to examine the allegation against opposite party-8. There is no evidence to prove that opposite parties-4 to 7 have committed any negligence.

O R D E R

In view of the aforesaid discussions, the complaint is partly allowed with cost of Rs. One lac. Opposite parties-1 to 3 are jointly and severally directed to pay Rs.35/- lacs as compensation with interest @6% per annum from the date of filing of this complaint till the date of payment to the complainant within two months from the date of this judgement. It shall be open to opposite parties-1 to 3 to adjust Rs.25/- lacs, if already paid.

..................................................J RAM SURAT RAM MAURYA PRESIDING MEMBER ...................................... SUBHASH CHANDRA MEMBER ................................................ DR. INDER JIT SINGH MEMBER

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