Shocking negligence: on need for materio-vigilance

A faulty prosthetics issue shows the need for a materio-vigilance programme to track devices

Published - August 31, 2018 12:15 am IST

An expert committee report on faulty hip prosthetics sold by a subsidiary of the U.S. firm Johnson & Johnson has revealed incriminating details about its negligence in dealing with Indian patients. The report, commissioned by the Union Health Ministry in 2017, was published this week. Though it restricts its criticism to J&J, the report makes it clear that the Central Drugs Standard Control Organisation also failed in its job of protecting Indian patients. It began in 2006, when DePuy International Ltd., a subsidiary of J&J, registered three types of articular surface replacement implants with the CDSCO. Made of cobalt, chromium and molybdenum, these were meant to replace ball-and-socket joints in patients with degenerative diseases. By 2007, the first indication that something was wrong came from the Australian Orthopaedic Association National Joint Replacement Registry. Its data showed that an extraordinarily high number of implant recipients had to undergo repeat surgeries. It emerged that the device was leaking cobalt and chromium, causing side-effects. Australia recalled the product in 2009.

Yet, the report says, J&J did not inform the Indian regulator and Indians kept using the implants until the firm began a voluntary global recall in 2010. In the following years, J&J’s actions in India differed widely from those in other countries. While it began corrective surgeries almost immediately in the U.S., the first Indian surgery happened in 2014. The company claims it had trouble tracking patients in India; of 4,700 implants done, only 1,032 recipients had been contacted till March 2017. J&J paid $2.47 billion in claims to about 8,000 patients in the U.S., but no Indian patient received compensation. If these facts are troubling, so is the CDSCO’s ineptitude in ensuring patient safety. Though the global recall occurred in 2010, the drug regulator did not issue an alert until 2013. Another learning is the importance of a materio-vigilance programme to track adverse events of medical devices. India established one in 2015. But if a programme along the lines of Australia’s NJRR had existed in 2006, perhaps Indian patients would have received help sooner. Even today, eight years after the recall, the Indian government seems to be in no hurry to take things forward. After the expert committee report was published, Health Minister J.P. Nadda said the government was still “deliberating” on the issue. With an unknown number of implant recipients still unaware that they could have received a faulty device (J&J hasn’t disclosed the number of recipients), time for deliberation is past. The authorities must show that when private corporations fail to protect patient interests, they will be held accountable.

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