In a bid to provide relief to patients affected by the global recall of Johnson and Johnson's faulty hip implants in 2010, the Union ministry of health and family welfare has directed states and union territories to form “state level committees” to determine the exact amount of compensation for affected patients.
The order comes in the wake of an expert committee report submitted to the Union health ministry in February. Last month, the report, a comprehensive document on Johnson and Johnson’s faulty hip implants and those affected by it, was made public after several media reports were published on the issue.
In 2010, the company's Acetabular Hip Resurfacing System (ASR) implant was recalled globally because of concerns over metal poisoning, and consequently, a high rate of revision surgeries.
In India, the product was sold by DePuy International, a subsidiary of Johnson & Johnson.
In its report, the government-appointed committee found the company to be “evasive” on several issues such as the design of the implants, details of patients who received it, compensation, and “follow-up adverse drug reaction” reports. In its order dated August 30, the Union health ministry said that it has accepted all the recommendations made by the expert committee on the issue, with a few modifications.
Instead of regional committees —the expert committee had asked these committees to determine the exact amount of compensation to be paid to the affected patients —the ministry has asked for state-level committees to be set up. These state level committees, together with an expert committee of the Centre, will determine the exact sum, according to the latest order. The amount, it says, “as admissible under appropriate law” will be determined on the basis of factors such as the degree and percentage of disability (due to the faulty implant) and loss of wages for the patient. The “base amount” for compensation, as set by the expert committee, has been fixed at Rs 20 lakhs.
However, patient representatives said that the decision would not help in providing them any relief. “Firstly, we feel that the regulator should not have allowed a ‘voluntary recall’ but rather a mandatory recall based on the high failure rate (of the hip implant). Besides, there are ambiguities around the upper limit of compensation. Also, it is unclear what law will be used to calculate the loss of wages,” said Mumbai-based Vijay Vojhala, who got a hip replacement surgery in 2008. Since then, Vojhala, a medical representative, has had to quit his job, and has been in severe pain despite a revision surgery. Vojhala also said that unless patients were made part of the committees, the process would lack credibility.
“Coming after an unconscionable delay by CDSCO, which has prolonged the suffering of the patients, we hope the compensation mechanism is enforceable,” said Malini Aisola of the Campaign for Dignified and Affordable Healthcare (CDAH), a forum of patients and families, and civil society groups. “It remains to be seen whether the compensation will be ‘just’ as recommended by the expert committee, as the quantum is likely to fall much short of what J&J has compensated patients in the US,” she said.
Besides, a majority of patients are still untraceable and will not able to access compensation until they are found, Aisola added. “We would hope that a system will be put in place for all devices/drugs that lead to adverse events after approval.”
Despite several attempts, Dr S Eswara Reddy, Drugs Controller General of India, could not be reached for a comment.