Government awards Delhi patient Rs 67 lakh for faulty J&J implant
The Central Drugs Standard Control Organisation (CDSCO), India’s regulatory body for pharmaceuticals and medical devices, has directed J&J to pay the compensation amount to the Delhi patient within 30 days from the date receipt of the order, which was sent out a week ago.Updated: Apr 05, 2019 07:49 IST
The government has awarded Rs 67 lakh as compensation to a Delhi resident who had received a faulty Johnson & Johnson’s (J&J) hip implant before August 2010, according to people familiar with the matter.
The Central Drugs Standard Control Organisation (CDSCO), India’s regulatory body for pharmaceuticals and medical devices, has directed J&J to pay the compensation amount to the Delhi patient within 30 days from the date receipt of the order, which was sent out a week ago.
“The orders have been issued,” confirmed Dr S Eswara Reddy, drug controller general of India (DCGI).
Ten patients are being considered for compensation in Delhi, said Delhi government officials.
The company has to submit a receipt from the patient that the compensation has been paid to CDSCO within a month.
At least 200 applications are under consideration by state-level committees for compensation from patients who received the faulty Articular Surface Replacement (ASR) hip implant in India.
The faulty ASR hip implants manufactured by DePuy International Limited, a subsidiary of J&J Pvt Ltd, were recalled in 2010 globally with complaints of more than usual revision surgeries because of complications such as metal leaching and infections, among others.
The health ministry then set up an 11-member committee on February 7, 2017, to investigate patient complaints of adverse events against the implant. The report was submitted in February 2018 and had recommended a base amount of ₹20 lakh.
Based on the recommendations, the government constituted a central expert committee under the chairmanship of Dr RK Arya, director, Sports Injury Centre of Safdarjung Hospital, to determine the quantum of compensation.
The compensation amount was to be calculated on a case-to-case basis depending on the age and the level of disability of the person, with younger people with higher disability getting the maximum compensation.
All states were asked to form a state-level committee, to track and verify eligible patients, and to come up with an amount on the basis of the central committee’s formula.
The first compensation of ₹75 lakh was awarded to a patient in March this year.
A J&J spokesperson said, “Johnson & Johnson Private Limited remains committed to providing assistance, including appropriate compensation within an established framework, to ASR patients in India who have undergone revision surgery. The formula for compensation needs to be within a fully transparent framework arrived at through due process. As the matter is sub judice, we won’t be able to further comment.”