Johnson & Johnson Asked To Pay Rs 20 Lakh Each To Patients Affected By Faulty Hip Implants
Central Drugs Standard Control Organisation (CDSCO), the national regulatory body for Indian pharmaceuticals and medical devices on September 4 sent a letter to the global health giant Johnson & Johnson and has asked it to pay Rs 20 lakh each as interim compensation to all those patients who had suffered from the company’s faulty hip implants.
According to the Times Of India, the details of the directive are in line with the recommendations of the central-government appointed 11-member expert committee which examined the issue related to the faulty J&J hip implants in February 2017. The committee, headed by Dr Arun Agarwal, who is a former dean of Maulana Azad Medical College, submitted its report earlier in 2018.
Central Government forms a five-member expert committee
Among other things, the said committee also recommended the formation of central and regional committees to facilitate patients in getting the compensation. Moreover, it said that J&J should continue their reimbursement programme for revision surgeries until August 2025, since the average life of an orthopaedic implant is 15 years. The company had terminated its programme in 2017.
Keeping in line with the recommendations, the Central government has constituted a five-member expert committee to recommend the compensation for the suffering patients. According to Hindustan Times, the new five-member committee reportedly includes bone and joint specialists among others and includes Dr RK Arya from Safdarjung’s Sports Injury Centre, Dr CS Yadav from AIIMS, Delhi; Dr Vineet Sharma from KGMU, Lucknow; Dr Bikas Medhi from PGIMER, Chandigarh; and Professor BT Kaul from Delhi University’s law department.
Affected patients to be evaluated by committees
The expert committee will review the reports of the state-level committees or applications of those affected based on a number of parameters. The Union Health Ministry is reported to have written to all state governments where it has asked for the formation of state-level committees. The letter also asked the state governments to issue advertisements so that the affected people can get help easily.
J&J has informed CDSCO that around 4,700 patients in the country received their ASR hip implants out of which about 3,600 patients are yet to be traced. Times Of India also reported a CDSCO official as saying that all the patients would be evaluated individually, to understand the extent of damage that came about as a result of bad implants after which, the compensation will be enhanced accordingly.
What went wrong with the J&J hip implants
The ASR hip implant, produced by DePuy Orthopaedics Inc, a division of Johnson & Johnson was reported to have been first cleared by the United States Food and Drug Administration (USFDA), However, after the rising number of revision surgeries, J&J initiated a global recall of the implants in 2010. According to Deccan Herald, the company continued to sell the implants in India till 2013.
The Union Ministry’s 11-member expert panel found that the increased wear from metal on metal implants resulted in an elevated level of cobalt and chromium in the blood which led to toxicity and ultimately, damage to tissues and other organs of the body. For their faulty implants, the company has faced lawsuits from patients all over the world. Reportedly, the company in the USA had agreed to pay $2.5 billion to 8000 patients in 2013. A J&J Medical India spokesperson said, “We are reviewing the report and look forward to discussing it with the government,“ reported Times Of India. The company had earlier claimed that the implants worked well for many other patients.