Johnson & Johnson had marketed the ASR (articular surface replacement) implants in India through its subsidiary DePuy between 2004 and 2010.
Nearly three months after the Health Ministry approved a formula to compensate patients fitted with Johnson & Johnson’s controversial ASR hip implants in India, the national drug regulator has directed the medical device giant to pay a Maharashtra-based patient over Rs 74.5 lakh.
“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 Central Drugs Standard Control Organisation (CDSCO) said Sunday.
J&J is currently locked in a court battle against the government challenging the compensation formula, which would make patients eligible for amounts between Rs 30 lakh and Rs 1.23 crore, depending on their age and level of disability.
On March 8, a central expert committee to recommend compensation for these “faulty” hip implants examined an application of a patient from Maharashtra, the CDSCO stated Sunday.
“The Central Expert Committee after examining the documents as well as the recommendation of State Level Committee, is of the considered opinion that the patient implanted with faulty ASR Hip Implant on both hips and subsequent revision of left hip, is entitled for the financial compensation as per the formula,” it said.
“Based on the recommendations … CDSCO has issued direction on 08.03.2019 to M/s Johnson & Johnson Pvt Ltd to pay the sum of Rupees 74,57,180/-…within a period of 30 days from the date receipt of the order as compensation amount to the patient and submit a copy of acknowledgment from the patient about the compensation paid to CDSCO within the said period,” the CDSCO said.
J&J declined comment on the CDSCO directive.
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