On the issue of J&J’s hip implant devices, manufactured by its subsidiary DePuy Orthopaedics Inc, Central Drugs Standard Control Organisation (CDSCO), has made the report public by putting it on its website which it had submitted to the government in February 2018.
After over a year of deliberation, the Central Drugs Standard Control Organisation’s (CDSCO’s) committee issued a 121-page report calling for a base payment of at least about $28,300 (Rs 2 lakhs)per patient, with final totals decided individually, and an extension of the company’s reimbursement program through 2025.
The committee has recommended compensation of at least Rs 20 lakhs to each affected patient, it has also asked company to do all necessary medical tests of patients and create awareness amongst patients, and that the reimbursement programme for revision surgeries continue until August 2025.
The panel found that over 3,600 patients with the faulty implants remain untraceable, and that at least four patients with the implants have died.
Accordingly, Johnson and Johnson will have to compensate patients in India adversely affected by ‘faulty’ hip replacement surgery using the company’s implant. The health ministry has asked states to set up committee to receive complaints.
“The ASR hip implants were found to be faulty, which resulted in higher revision surgeries,” the report said. 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,” the report said.
Manufactured by its subsidiary DePuy Orthopaedics Inc, J&J’s hip implant devices, were first cleared by the United States Food and Drug Administration (USFDA) in 2005. The firm then recalled the devices on August 24, 2010.
One of the patient who is affected by faulty hip implant, Vijay Vojhala, said, “The figure of Rs 20 lakh compensation is ambiguous. We would like to know how this figure is estimated. We would expect more compensation. But, since neither the government nor the company has come up with any concrete statement on the report be included we all patients would wait for their statement first. But we would like us all to be included in the process of redressal.”
The CDSCO’s committee also recommended the creation of an independent government registry for tracking the usage of high-risk medical devices, analysing performance and usage, and potentially with legal backing to issue warnings and alerts to manufacturers – as well as CDSCO guidance on effective device recall practices.
In addition, ASR patients should have their health checked every year, including routine physical follow-ups, x-rays and soft tissue imaging, as well as blood tests for levels of cobalt and chromium from the metal implant.