India’s drug safety regulator CDSCO has directed Johnson & Johnson (J&J) to pay a compensation of Rs 74.6 lakh to India’s first patient affected by faulty hip implants from the American company, reports The Hindu BusinessLine (BL).
The case relates to the FIRs filed by affected victims of malfunctioning implants with Maharastra’s Food and Drug Administration. In its investigation, the authority concluded that J&J’s Articular Surface Replacement (ASR) hip implant had failed in certain patients, resulting in leaching of metals in the patients’ blood. This malfunction further caused the joint to deteriorate.
The compensation of Rs 74.6 lakh to be paid to the victim was arrived at by a state-level committee from Maharashtra headed by RK Arya, Director of Safdarjung Sports Injury Centre.
Noting that similar committees have been set up in other states, a government note said, “Various State-level committees were also formed to examine issues faced by patients, identify the affected ones and make the process less arduous for them."
In 2010, J&J had voluntarily recalled 93,000 ASR hip implant systems across the world, stating that 12 per cent of them had failed over five years. Though the company agreed to pay damages of $2.5 billion to around 8,000 affected US citizens, the company has been criticised for failing to pay any compensation in India.
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