The Central Drugs Standard Control Organisation on Sunday ordered Johnson & Johnson to pay over Rs 74.5 lakh as compensation to a patient from Maharashtra who used faulty hip implants manufactured by the pharmaceutical giant. The authority, which is part of the Ministry of Health and Family Welfare, said it issued the directive on March 8, and that the amount must be paid within 30 days, The Hindu reported.
“This is the first case where M/s Johnson & Johnson has been directed to pay compensation for the Faulty ASR Hip Implant manufactured and imported by M/s DePuy International Limited [now Johnson & Johnson Pvt Ltd],” the authority said, according to The Indian Express. The patient received faulty implants in both hips, and had to subsequently undergo revision surgery on his left hip.
The devices were first cleared by the United States Food and Drug Administration in 2005. After red flags were raised in the wake of rising revision surgeries, the firm recalled the devices on August 24, 2010.
The patients had to undergo revision surgeries due to severe pain in the hip, inability to walk, destruction of bone and deposition of harmful metal debris of the implant inside body tissue.
On October 5, the Supreme Court asked the Centre to respond to a petition alleging that more than 15,820 people have been fitted with faulty hip implants. A central committee appointed to consider compensation packages for patients decided they would be paid between Rs 30 lakh and Rs 1.23 crore. In November, the Supreme Court accepted the Centre’s formula.
Johnson & Johnson refused to comment on the ruling, The Indian Express reported.