A logo sits on a wall inside Johnson & Johnson’s innovation centre. (Courtesy: Simon Dawson/Bloomberg)

J&J’s Faulty Hip Implants: Is Rs 20-Lakh Compensation Enough?

Vijay Anant Vojhala is among 4,700 patients in India who had a faulty hip implant made by Johnson & Johnson. “I suffered from problems with vision and hearing after I was fitted with the device,” he said. And he is livid. Not just because he had to get operated the second time to replace the device, but also how little compensation he may get.

A panel set up by the Central Drug Standard Control Organisation suggested a base compensation of Rs 20 lakh for each patient, calculated based on the minimum wage.

“I only got my revision surgery cost back. The company has never shown interest in compensating me, saying there’s no provision for compensation and it will be considered illegal,” Vojhala, who testified before a government committee, told BloombergQuint. “I want to understand what exactly is the expert committee’s logic behind the baseline compensation.”

“Each U.S. victim gets a compensation of Rs 7 crore and to an Indian it is Rs 20 lakh?”

The Indian unit of Johnson & Johnson, according to a report by an expert committee of the Union Ministry of Health and Family Welfare, suppressed key facts on the ill effects of surgeries conducted on patients in India using imported hip implants that were faulty, the Indian Express first reported.

DePuy ASR, part of the J&J group, said in a statement that a voluntary recall doesn’t imply that the product is “faulty” nor does it imply that every patient who has received a hip implant will necessarily have to undergo revision surgery. The company, however, said it doesn’t have access to data on patients who received an ASR hip implant due to confidentiality regulations, and has requested surgeons and hospitals to reach out to them.

Citing his own experience, Vojhala, however, said there was no proper tracking of patients even after the company recalled the implants. He attributed it to “lethargy” on the part of the regulator and the company, saying no payout was enough to compensate what he went through.

Consumer activist Bejon Mishra, a member of the expert committee that fixed the compensation amount, agreed that compensation amount suggested wasn’t enough. Several members agreed on this figure so that there was a consensus, he said.

Under the Clinical Establishment Act, there is a formula that the government has already determined and made it a regulation for patients who have lost their lives or due to damage caused by clinical trials. The compensation calculation was done in a similar manner. The government is keen on framing a possible compensation mechanism. Yes, I admit that this compensation is not adequate. We don’t even have a proper law in our country. It cannot be a formula which can be applied to everybody. It also has to be based on the victim’s profile.
Bejon Misra, Member, Expert Committee on Faulty ASR Hip Implants   

The expert committee’s report has indicted DePuy for not providing details of patients who were fitted with the faulty hip implants. A total of 15,892 of these devices were imported to India between February and August 2010.

The company recalled the devices worldwide after patients complained of adverse reactions that were above normal. DePuy was forced to recall the implants in Australia in 2009, followed by the U.S., Canada, U.K., Brazil and India a year later.

The victims in India, said independent lawyer Murali Neelakantan, can also approach the consumer forum for relief but that could be a drawn-out process. “Doctors and hospitals are complicit in this,” he said. “Even if they didn’t know at the time of surgery that the implants could cause trouble for the patients, what did they do as soon as they got to know about it? If patients could come and tell us who these doctors and hospitals are, we could have a list to start from.”

Watch the full discussion here: