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CDSCO directs Johnson & Johnson to pay Rs 74.5 lakh to first patient with faulty hip implant

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This is the first case where M/s Johnson & Johnson has been directed to pay compensation for its faulty ASR hip implant

Based on the recommendations of the central expert committee and the state-level committee, CDSCO has issued direction on 08th March, 2019 to M/s Johnson & Johnson to pay the sum of Rs 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.

This is the first case where M/s Johson & Johson 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.).

With regard to it, an expert committee was constituted by the Ministry under the chairmanship of Dr Arun Kumar Agarwal, Ex-Dean and Professor, ENT, Maulana Azad Medical College, New Delhi to examine the issues relating to faulty ASR Hip Implants manufactured by DePuy International, UK (M/S Johnson & Johnson). The committee, after detailed examination of the issue, submitted its report alongwith its final recommendation. The report was accepted by the central government.

Based on the recommendations, the government constituted a central expert committee under the chairmanship of Dr RK Arya, Director, Sports Injury Centre to determine the quantum of compensation. On request of the Ministry of Health and Family Welfare (MoHFW), government of India, various state/UT governments have also constituted state-level committees to examine the affected patients within the respective states and to make the process less arduous for the patients. These committees send their recommendations to the central expert committee for consideration.

The committee, after detailed deliberations, has prepared a formula for determining compensation for the ASR victim patients. The MoHFW has accepted the formula vide its order dated 29th November, 2018 prepared by the expert committee, paving the way for patients to secure compensation from M/S Johnson & Johnson for faulty hip implants.

In accordance with the Dr Aggarwal Committee report, application of one patient from Maharashtra was examined by the state-level committee constituted by the government of Maharashtra. The state -level committee had forwarded their recommendation to the central expert committee, alongwith various documents including the disability certificate issued by the Medical Authority, Mumbai, Maharashtra for further necessary action.

The recommendation, as received from the state-level committee, was perused and examined by the central expert committee in its meeting held on 8th March, 2019.

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.

As per the formula, the central expert committee has recommended for payment compensation of Rupees 74,57,180/- (Rupees Seventy-Four Lakhs Fifty-Seven Thousand One Hundred and Eighty only) to the patient.

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