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Ex-FDA chief Mahesh Zagade had started looking into the faulty implants when he was leading FDA. He found 4,000 patients pan-India who became disabled due to ASR implants. Photo: ReutersPatients affected by Johnson and Johnson’s faulty implants opened up about their current situation and felt the committee set up to provide them compensation is ‘one-sided’.
They went on to question the committee’s composition and the checks and balances that the government has thought of, to ensure fair play.
Patients and families addressed the press in the capital on Saturday. “What are the checks or balances on the working of the committees? What is the guarantee that the committee will be fair, just, equitable and reasonable in determining compensation,” asked Vijay Vojhala, who had his initial surgery in 2008 and the revision in 2012.
They feel that the government is doing a one-sided inquiry and this could be at the cost of the patients not getting enough compensation. The expert committee to decide compensation for these patients has been set up after the committee investigating the faulty implants recommended a compensation to patients.
These patients and patient help group All India Drug Action Network are of the opinion that irrespective of injury, all 4,000-plus patients should be paid compensation who got the articular surface replacement (ASR) implant.
“One ought not to wait for harm to occur, when a device has been shown to be harmful the world over as well as in India. For me there is an element of discrimination in how J&J is treating Indian patients and those in developed countries,” said Kabbir Chandhok , an affected party.
Former Food and Drug Administration (FDA) chief Mahesh Zagade had started looking into the faulty implants when he became FDA chief and he had found more than 4,000 patients pan-India who became disabled due to ASR implants.
Zagade said: “The government is jointly and severally liable.” Zagade added that the regulator should ensure an incident like this does not occur again. The Committee constituted to look into compensation will meet on September 18. They will come up with a set of guidelines that will be used to screen these patients and assess their disability.
The drug controller, however, is claiming that it will ensure fair compensation. People in the know say the regulator will even move court if the company does not comply with the committee's decision. The base compensation will be Rs 2 million, but it could be more based on the disability.