NEW DELHI:
Accepting the recommendations of the expert panel with some modifications, the Union Health Ministry has formed a Central committee and has directed states to form committees at their level to determine the size of compensation to patients, who have been affected due to faulty hip implants of Johnson and Johnson (J&J).
“State level committees, instead of regional committees (as recommended by the expert panel), 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 (Central or State),” said a notification dated August 30, 2018.
The expert panel, which submitted its report on February 19, recommended that the company should be made liable to pay at least Rs 20 lakh to each affected patient and that the reimbursement programme for revision surgeries continue until August 2025.
“The Central Committee shall review the report of the State level committee and also other documents submitted by the patients. Quantum of the compensation would be decided by the Central Expert Committee based on the following: base amount of Rs 20 lakh; degree of disability; patient suffering on account of monetary loss of wages and other losses; percentage disability of the patients,” the notification added.
Johnson & Johnson Medical India spokesperson said Tuesday: “We are reviewing the report and look forward to discussing it with the government”.
The key findings of the panel include constitute the first official indictment in India against J&J, which imported and sold ASR XL Acetabular Hip System and ASR Hip Resurfacing System in the country — these devices were globally recalled in 2010. The panel found that over 3,600 patients with these implants remain untraceable, and that at least four patients have died.
In another notification dated August 30, 2018, the health ministry has formed the Central committee to determine the quantum of compensation to patients. R K Arya, Director at Sports Injury Center in Safdurjung Hospital, has been appointed as the chairman of the panel. Two orthopaedic doctors, one professor of pharmacology and one law professor are the other members.
Vijay Vojhala, one of the affected patients, stated on Tuesday: “The track record of the government on transparency and accountability to patients in the process leading up to this has been abysmal. Moving forward from here we need utmost transparency. We ask that there is participation of patients in committees. Else, they would lack credibility.”
As per Central government, the state level committee would have the following members: two orthopaedic surgeons or physical medical rehabilitation experts from government hospitals; one radiologist from government hospital; one zonal or sub-zonal official of central drug regulator; one official of state drug regulator.
J&J’s hip implant devices, manufactured by its subsidiary DePuy Orthopaedics Inc, were first cleared by the United States Food and Drug Administration (USFDA) in 2005. Following red flags on the rising number of revision surgeries, the firm recalled the devices on August 24, 2010.
The Union health ministry’s expert panel had concluded in its February report: “…the ASR hip implants were found to be faulty, which resulted in higher revision surgeries”; the “…accelerated wear of metal on metal implant leads to higher levels of cobalt and chromium in the blood which lead to toxicity… these metal ions damage tissues and further damage body organs” and “may also cause localised and systematic health problems”.
All of this, the panel found, “results in increased pain and decreases mobility affecting their family and social life” and has “a negative impact on their self esteem and mental health”.
