While senior government officials claimed that Johnson & Johnson (J&J) had agreed, in-principle, to pay compensation to the patients affected by its faulty hip implants, the company maintained it had the global expertise to arrive at a compensation mechanism on a case-to-case basis for each patient.
The government has fixed a minimum compensation amount of Rs 2 million for each affected patient, but J&J wants to arrive at a ‘mutually agreeable’ figure that need not be the same as the government has recommended.
Meanwhile, J&J has also claimed that it has reached out to almost 50 per cent of patients, who had an ASR hip implant made by DePuy, a J&J subsidiary. Its aim is to have all the 4,700 patients (who underwent an ASR hip implant surgery in India) register on the ASR helpline soon with help from the government, the company said.
Sushobhan Dasgupta, managing director, J&J Medical India, said, “We want to arrive at a compensation amount that is fair and equitable for each patient. We have the global expertise to arrive at a compensation mechanism for the same, and would work closely with the Indian government on this.”
DePuy set up a helpline and initiated the reimbursement process for ASR patients in India in September 2010.
He also said while 2,300 patients had already been reached out to and 277 revision surgeries had been conducted, not all patients were unhappy with the ASR hip implant. “There are happy ASR-hip implant patients too. My mother, an 87-year-old lady, had undergone an implant surgery (using ASR implant) about 11 years ago, and she is doing fine. In fact, she travelled alone from Kolkata to Mumbai recently,” Dasgupta quipped. The first hip implant (a locally made one and not a J&J product) that was administered to his mother had failed within three months, after which she had gone for a revision surgery and received an ASR hip implant, he said.
There has been a five-year revision rate of 12-13 per cent for ASR hip implants globally, which is higher than the expected rate. So far in India, the company has paid around $2 million to patients for revision surgeries, and around $250,000 in related diagnostic costs, under its ASR reimbursement programme.
“We are open to pay for revision surgeries, if needed, and diagnostic costs, loss of wages, physiotherapy and other needs. The patients can choose to go to surgeons of their choices. We are already running a reimbursement programme. As for compensation, we want to go on a case- to-case basis and arrive at a mutually agreeable figure,” Dasgupta said.
J&J tried to clarify that a voluntary recall did not imply that the product was ‘faulty’. “A voluntary recall doesn’t imply that the product is faulty nor does it imply that every patient who has received an ASR hip implant will necessarily have to undergo revision surgery. Indeed, ASR continues to function well for many patients in India and around the world,” the company spokesperson said.
The expert committee constituted by the Union health ministry had recommended that each patient be identified through regional and central committees, which would put out advertisements in newspapers, register patients, evaluate the disability suffered owing to ASR hip replacements, and accordingly arrive at a compensation amount. The base amount for compensation was fixed at Rs 2 million. The amount was decided such that if a patient keeps it in a bank by means of a fixed deposit (at 7 per cent interest), he or she would get a monthly interest amount equivalent to his/her minimum wages per month. For example, the minimum monthly wage of an unskilled worker based in Delhi as of March 2017 was Rs 13,350.To earn this, a deposit of over
Rs 2 million would be required to be kept in a bank account.
A senior government official said the company had already given an undertaking in which it had agreed, ‘in-principle’, to provide compensation to the affected patients.
“They have some issues with the protocol for arriving at the compensation amount for each patient. We have also asked them to share the details of the protocol that they had used in the other countries such as US and Australia,” the official said.
The apex drug regulator had sent a letter to the company on Tuesday, asking it to comply with the recommendations of the government-appointed expert committee.
A J&J Medical India spokesperson said, “In the light of the recent committee report, we are seeking to work with the Indian government to develop an appropriate process for providing further support and compensation to patients in need.”
The US-based medical devices maker has been under fire, off late, for the faulty ASR hip-implants and its failure to identify the affected patients, and offer a resolution. The artificial hip implants were recalled worldwide by the company in 2010. Around 93,000 patients were had received ASR implants globally.