A government panel has recommended that Johnson & Johnson (J&J) pay compensation of at least $28,500 (approximately Rs 20 lakhs) to each Indian patient who suffered from artificial hip implants the U.S. healthcare firm recalled eight years ago. The ASR hip implants were recalled in 2010, after data suggested they failed at a higher-than-expected rate.
After over a year of deliberation, the Central Drugs Standard Control Organisation’s (CDSCO’s) committee issued a 121-page report calling for a base payment of at least about $28,300 (Rs 2 lakhs)per patient, with final totals decided individually, and an extension of the company’s reimbursement program through 2025.
The committee has recommended compensation of at least Rs 20 lakhs to each affected patient, it has also asked company to do all necessary medical tests of patients and create awareness amongst patients, and that the reimbursement programme for revision surgeries continue until August 2025.
The panel found that over 3,600 patients with the faulty implants remain untraceable, and that at least four patients with the implants have died.
Reportedly over 4,500 patients in India had received this implant, and J&J is said to have reported over 100 serious adverse events to the Central Drugs Standard Control Organisation between 2014 and 2017.
Accordingly, Johnson and Johnson will have to compensate patients in India adversely affected by ‘faulty’ hip replacement surgery using the company’s implant. The health ministry has asked states to set up committee to receive complaints.
Now, the central government has taken a decision to constitute a central expert committee to determine the quantum of compensation in respect of faulty ASR hip implants manufactured by DePuy International Limited, UK and implanted in India.
The committee shall compromise the following, Dr R.K. Arya, Director, Sport Injury Centre, Safdarjung Hospital, New Delhi as the chairperson of this committee and its members will include Dr C.S. Yadav, Department of Orthopaedics AIIMS, New Delhi, Dr Vineet Sharma, HOD, Department of Orthopaedics, KGMU, Lucknow, Dr Bikas Medhi, Professor, Pharmacology, PGIMER, Chandigarh and Bushnan Tilak Kaul, Professor of Law, Delhi University, New Delhi.
While speaking to My Medical Mantra, Vijay Vojhala, a patient who was affected by a faulty hip implant and has been fighting this case against Johnsons & J since the last eight years said, “The ambiguity has to be clarified and read out. How can the compensation be fixed for everyone? How can you compensate everyone with the same generalisation? How are people being going to be taken care of? It took the government eight years to come to this stage!”
He further said, “The health ministry has to ensure that the company must bear the medical expenses for the lifetime of each patient. Because we don’t know what is going wrong in our body and the company should bear all the cost for whoever is due for another revision surgery company. And most definitely the compensation has to be better than what is paid globally.”
The union government has also asked the states to formulate state level committees. The committee should comprise the following:
- Two orthopaedic surgeons/ Physical Medical Rehabilitation (PMR) experts from Govt Medical College and Hospital.
- One Radiologist from Govt Medical College and Hospital.
- CDSCO Zonal/Sub Zonal Office representative.
- Drug Controller of respective state as Member Secretary.
Advertisements are to be brought out by respective state governments/ UT administration in newspapers so affected patients can approach the State Level Committee.