New Delhi: The Ministry of Health & Family Welfare, Government of India approved the formula for determination of compensation for those patients who had received (prior to August 2010) faulty Articular Surface Replacement (ASR) hip implants manufactured by M/s. DePuy International Limited, U.K (M/S Johnson & Johnson Pvt Ltd).
With the new formula, patients suffering from the faulty implants are likely to get a compensation upto Rs 1.2 crore each. The formula includes a base compensation of Rs 20 lakh and an additional Rs 10 lakh for ‘non-pecuniary’ damages, which are damages that cannot be readily quantified. Earlier a block compensation had been fixed by a government committee at Rs 20 lakh .
This is the first initiative of compensation being paid for sub standard treatment in the country
The genesis of the case goes back to the year 2010 when a hip replacement device namely DePuy ASR was recalled over reports of metal poisoning and high failures due to the presence of toxic chromium, cobalt and a design flaw that filtered into the body, causing danger to lives. It was sold in India by DePuy International, a subsidiary of J&J.
4,500 patients in India had received this implant, and J&J is said to have reported over 100 serious adverse events to the Central Drugs Standard Control Organisation (CDSCO) between 2014 and 2017.
An expert committee was constituted by the Ministry under the Chairmanship of Dr Arun Kumar Agarwal, Ex-Dean and Professor of ENT, Maulana Azad Medical College, New Delhi to examine the issues relating to faulty ASR Hip Implants. The committee, after detailed examination of the issue, submitted its report along with 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 R.K. Arya, Director, Sports Injury Centre to determine the quantum of compensation. All the State/UTs Government have also been requested by the Ministry to form State Level Committees to examine the affected patients within the respective states and to make the process less arduous for the patients. These committees would send their recommendations to the Central Committee.
All the State/UTs Government had also been requested to make people aware through newspaper advertisements so that they may approach either Central Expert Committee or State Level Committee.
Dr R.K. Arya, Chairman, Central Expert Committee after holding five meetings prepared a formula for determining compensation for the ASR victim patients. This reads as
B x R x F + Rs 10 lakh towards non-pecuniary damages.
B is the base amount i.e., Rupees Twenty Lakh (Rs 20,00,000)
R is the Risk Factor-Disability
F is the Age Factor
Risk Factor (R )
|Percentage Disability||Risk factor to be assigned|
|20% – 30%||1|
|30% – 40%||1.5|
|40% – 50%||2|
|50% & above||2.5|
Age Factor (F)
|65 & more||99.37|
For easy understanding of the patients, illustrative cases of the amount of compensation payable to the patients with ASR Hip implant with disability in relation to their Age and Percentage Disability would work out as below:
|Age||Age Factor as per Clinical Trial Formula||Compensation Amount (in lakhs) for Disability 20-30%
(Risk Factor 1)
|Compensation Amount (in lakhs) for Disability 30-40%
(Risk Factor 1.5)
|Compensation Amount (in lakhs) for Disability 40-50%
(Risk Factor 2)
|Compensation Amount (in lakhs) for Disability50% above
(Risk Factor 2.5)
|65 & above||99.37||30.00||40.00||50.00||60.00|
The Government today accepted the formula prepared by Central Expert Committee, paving the way for patients to secure compensation from M/S Johnson & Johnson Pvt Ltd in days to come. Compensation will be paid in a time-bound manner through bank accounts of affected persons by M/S Johnson & Johnson Pvt Ltd.