The Central drug regulator has instructed pharmaceutical MNC Johnson and Johnson (J&J) to pay a compensation of over ₹74.5 lakh to the first patient in India affected by the company’s faulty hip implants, said a press note issued by the Drug Controller General of India (DCGI).
The first patient to be compensated hails from Maharashtra. The State-level committee formed to look into the patient’s issue had forwarded its recommendation to the central expert committee along with various documents including the disability certificate issued by a medical authority in Mumbai.
“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,” said the note.
The compensation amount was arrived at by a committee through a formula that was devised to calculate the expenses in each patient’s case. The committee that decides on the compensation is headed by RK Arya, Director of Safdarjung Sports Injury Centre.
The issue had come to light when the Food and Drug Administration of Maharashtra had sought to investigate an FIR against J&J by the affected victims. It was found that J&J’s Articular Surface Replacement (ASR) hip implant had failed in certain patients, allegedly leading to leaching of metals in the patients’ blood, causing the hip joint to deteriorate.
In 2010, the company had announced a voluntary recall of 93,000 ASR hip implant systems across the world, saying 12 per cent of them had failed over five years. The company has announced plans to pay at least $2.47 billion, and has since settled many lawsuits while others remain stuck in litigation at various levels.
Of the over 4,000 patients fitted with the ASR implant in India, just about 844 have been traced by the company till date.