J&J fined Rs74.5 lakh for its first faulty hip implant in India
11 Mar 2019
The central drug regulator has directed pharmaceutical major Johnson and Johnson (J&J) to pay an amount of Rs74.5 lakh as compensation to the first among several patients in India affected by the company’s faulty hip implants, a press note issued by the Drug Controller General of India (DCGI) stated.
The patient from Maharashtra was awarded the compensation after a state-level committee formed to look into the patient’s issue 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 varies from case to case and is based on a formula devised by a committee to calculate the expenses in each patient’s case. The compensation committee is headed by RK Arya, Director of Safdarjung Sports Injury Centre.
The problems with J&J’s hip implant were first noticed following an investigation by the Food and Drug Administration of Maharashtra into an FIR against J&J by some affected patients.
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.