A panel convened by the Indian drug and medical device regulator has recommended Johnson & Johnson compensate each Indian patient that had to undergo revision surgeries or suffered adverse reactions to its metal-on-metal hip implants recalled in August 2010.
J&J’s DePuy unit recalled 93,000 ASR hip replacement systems worldwide after data emerged showing earlier-than-expected replacement surgeries following implantation, with a 12% failure rate within five years in devices designed to last for two decades.
The company would later look to spend nearly $3 billion to settle and resolve claims stemming from more than 10,000 lawsuits, and J&J abandoned sales of metal hip replacements in 2013. In India, about 4,700 procedures were performed since they were made available in 2004.
After over a year of deliberation, the federal Central Drugs Standard Control Organization’s (CDSCO's) committee issued a 121-page report calling for a base payment of at least about $28,300 per patient, with final totals decided individually, and an extension of the company’s reimbursement program through 2025.
(J&J)
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The committee also recommended the creation of an independent government registry for tracking the usage of high-risk medical devices, analyzing 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.