NEW DELHI: The government has constituted a new central expert committee to determine how much patients with Johnson & Johnson’s ‘ASR’ hip implants should be compensated, according to a new document sent by the health ministry to the country’s apex drug regulator. Patients with health problems caused because of these implants, globally recalled in 2010 because more patients were found to require revision surgeries than normally reported for these devices, may be a step closer to receiving a payout.
The new central committee will be chaired by RK Acharya, the director of Safdarjung Hospital’s sports injury centre, and will consist of a total of five members, according to an order dated August 30.
At the same time, some patients are either unhappy with the proposed compensation or want more clarity on how exactly the final compensation amount will be determined.
The new committee has to determine the quantum of compensation that patients with these implants can receive within 45 days of receiving a report from the state committees that are also being set up to trace aggrieved patients.
The committee is also empowered to review applications submitted by affected patients to determine the compensation “as admissible under appropriate law”, according to the order. It will further recommend any medical management required.
According to a second notification sent to states on the same date, the committee has to calculate the compensation amount on a case-by-case basis, using details like degree of disability and patient suffering on account of monetary loss due to reasons like loss of wages.
Patients implanted with ASR who did not undergo any revision surgeries and patients who did not suffer any disabilities following one revision surgery are also eligible for compensation. Apart from this, patients with one or more revision surgeries suffering with disabilities and patients with ASR suffering from any other systemic disorder, where the cause is established, are entitled to compensation.
ET is awaiting response to queries sent to J&J and will update this story.
This committee has been formed upon recommendations of another expert group set up last year to look into the issue of these implants. The expert group submitted its report six months ago and recommended a base compensation of at least Rs 20 lakh as well as the extension of J&J’s ongoing reimbursement programme for revision surgeries until 2025.
These findings and recommendations were made public last week.
“State level committees, instead of regional committees, should be formed to enable hassle-free access to the patients as they can easily approach the state level committee in their respective states. The patients can also be given preference to approach either of the two committees,” said the notification.
“Coming after unconscionable delay by CDSCO, which has prolonged suffering of patients, we hope the compensation mechanism is enforceable. It remains to be seen whether the compensation will be ‘just’ compensation, as recommended by the expert committee as the quantum is likely to fall short of what J&J compensated patients in the US,” said Vijay Vojhala, one of the patients who received the ASR implants around a decade ago and had to undergo revision surgery within a few years.
In 2013, J&J agreed to a $2.5 billion settlement for around 8,000 patients in the US over the implants.