Health ministry accepts compensation formula for J&J

The Union Health Ministry has accepted a compensation formula that pharmaceutical major Johnson and Johnson will have to follow while paying several thousand Indian patients who received faulty hip implants manufactured by a subsidiary of the multinational company a decade ago.

According to the formula – released last night – the victims would receive anything between Rs 30 lakh and Rs 1.22 crore depending on their age and the extent of disability they suffer from.

The calculations were done by an expert panel, headed by R K Arya, director of the Sports Injury Centre, Safderjung Hospital here.

The Arya panel took into account the recommendation of another expert committee chaired by Arun Kumar Agarwal, former dean of the Maulana Azad Medical College who investigated the issues concerning faulty hip implants.

Agarwal committee recommended paying a minimum compensation of Rs 20 lakh to every victim. The Arya committee used that amount as the base and applied a mathematical formula depending on the patient’s age and the extent of suffering to arrive at the final figure.

“The government accepted the formula prepared by Central Expert Committee, paving the way for patients to secure compensation from Johnson & Johnson Pvt Ltd in days to come. Compensation will be paid in a time bound manner through bank accounts of affected persons by Johnson & Johnson Pvt Ltd,” the ministry said in a statement on Thursday.

A decade ago, DePuy International Ltd, a subsidiary of Johnson & Johnson flawed ASR XL Acetabular Hip System and ASR Hip Resurfacing System to the Indian market. Nearly 4700 Indian patients are suspected to have received those implants even though neither the company nor the government released the exact number of patients.

The implants had an inherent problem. Soon after the surgery patients developed pain because of the release of toxic cobalt and chromium – the two materials of which the implants were made of – in the body. Many had to undergo a revision surgery.

The company initially suppressed information and stopped supplied the faulty implants only after the Maharashtra Food and Drug Administration initiated action. There was no known use of the ASR hip implants after August 2010.

Not everyone is satisfied with the formula. “There are many things that have been left out. What about compensating patients who have not yet had a revision surgery or died. Further, there was no discussion on medical management and not a single dialogue with the patients,” said Malini Aisola from All India Drug Action Network.

“This formula will set a new benchmark. It will financially be a tall order for any manufacturer to service and open up the product liability insurance sector in India,” commented Rajiv Nath, forum coordinator, Association of Indian Medical Device Industry.