Implant Files: How J&J Sneaked in Another Faulty Medical Device
Did J&J slip in another faulty implant into the Indian market?
Did J&J slip in another faulty implant into the Indian market? (Photo: iStockphoto)

Implant Files: How J&J Sneaked in Another Faulty Medical Device

As the government approved reimbursement programme for patients affected by the faulty devices of Johnson & Johnson, the Supreme Court (SC) of India is likely to hear a public interest litigation (PIL) on the matter on 3 December.

Earlier, while all the attention was focused on how Johnson & Johnson used a loophole in the medical device system to push its faulty ASR hip implant devices in India, another faulty device made by them escaped attention.

In an investigative report filed by The Indian Express, it is revealed that while J&J officially recalled its ASR knee implants in 2010, it ‘commercially’ withdrew the Pinnacle hip implant device only in 2013. Both products have been found to be faulty.

As a result, while those who were using the recalled ASR implants are liable for compensation in India as the government officially pulled up J&J for suppressing facts, those who were implanted with the faulty Pinnacle hip implant device continue to seek justice.

The report is part of the global investigation by International Consortium of Investigative Journalists (ICIJ) and 59 media houses including The Indian Express.

Currently, those implanted with the ASR faulty knee implants are liable for compensation amounting up to Rupees 1.23 crores. 3600 patients who received the faulty implants remain ‘untraceable’ and the case is in the Supreme Court.

How Did Pinnacle Escape the Attention?

In a series of reporting earlier this year, including by FIT, it came to light how Johnson and Johnson was pushing it’s faulty ASR implants in India. The rot in the medical device system was exposed by FIT in this report here.

Also Read : An Unregulated Mess: Inside India’s Medical Device Industry

According to the investigation, Johnson & Johnson subsidiary DePuy waved the US clearance for Pinnacle and ASR to push both the products in India without any clinical trials here.

They used a loophole that the US Food and Drug Administration has.

There are two ways a device can be approved by the FDA – either under the premarket approval (PMA) or the 510(k) process. The former is more strict than the latter, but is still not as robust as the process for drug approval. The latter, a huge loophole, is also one under which majority of devices are approved.

It says that a device doesn’t even need to undergo the process of approval if it can be established that it is similar to a product already in the market.

While in India, the investigations by government agencies is focused on the ASR implants, in the US 8,000 patients have filed a class action suit against Johnson & Johnson over the faulty pinnacle implants.

Express spoke with several patients implanted with Pinnacle devices who claimed similar adverse incidents as the ASR implants. One patient they spoke with have one implant of ASR and Pinnacle each. And yet, they’ve not been covered under the current compensation being given out.

In a statement to Indian Express, J&J said ‘no adverse events in India’ have been reported to them vis a vis the pinnacle device.

Also Read : Implant Files: Inside the Murky Breast Implant Industry

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