J&J, however, has challenged these recommendations before the Delhi High Court, where it said that it would pay Rs 25 lakh each to 66 patients who underwent revision surgeries.On May 7, Johnson & Johnson agreed in a Texas court to shell out $1 billion to settle about 6,000 lawsuits filed against the global pharma giant by patients in the US who used its “defective” Pinnacle hip implants for 10 years from 2003 to 2013 before the product was withdrawn.
In India, the contrast is stark. Here, J&J is fighting a government order asking it to pay Rs 20 lakh to Rs 1 crore to patients who used its faulty ASR hip implants, a product that came after Pinnacle. And on Pinnacle itself, there is deafening silence.
Unlike ASR, J&J has claimed in India that it has received no adverse event reports on Pinnacle. Medical records accessed by The Indian Express show otherwise.
In November, an investigation by The Indian Express identified three patients suffering from the adverse effects of the Pinnacle implant. Now, there are four more — and counting.
Three of them say they didn’t even know that they had Pinnacle implants in their bodies and in at least two cases, there is a clear email trail that shows J&J knew things had gone horribly wrong.
Each of these patients has launched personal battles, knocked on doors. So far, they have hit a brick wall.
At the heart of their trauma is the leak of cobalt-chromium ions from the implant into the body, leading to serious health complications, including metal poisoning of the blood, debilitating pain, and damage to body organs.
Asked about adverse event reports of Pinnacle patients, a J&J spokesperson said: “As on date, we have no further updates to provide.” The spokesperson declined comment on the US settlement.
Read | Pinnacle safe, will keep you posted: Johnson & Johnson told Govt in 2011, went silent
Documents filed by J&J before the US regulator, Securities Exchange and Commission (SEC), in 2018 acknowledge that Pinnacle is one of the “most significant cases” of product liability claims for personal injury and that the “number of pending product liability lawsuits” related to the product “continues to increase.” It also reveals that there are 10,500 lawsuits related to Pinnacle alone in the US.
In the case of ASR in India, a government-appointed expert committee recommended last year that J&J be made liable to pay an estimated 4,000 patients at least Rs 20 lakh as compensation. Another committee appointed by the government recommended compensation up to Rs 1.22 crore.
J&J, however, has challenged these recommendations before the Delhi High Court, where it said that it would pay Rs 25 lakh each to 66 patients who underwent revision surgeries.
J&J recalled the defective ASR metal-on-metal implants globally in 2010 — it gained a licence to market ASR in India without clinical trials based on the earlier clearance given to Pinnacle by European regulators. It finally withdrew Pinnacle in 2013. But by then, the damage was already done.
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Malini Aisola, co-convenor of All India Drug Action Network (AIDAN), a patients’ rights group that has been approached by Pinnacle users following reports of faulty ASR implants, said: “Pinnacle has a sordid regulatory history much the same as the ASR. There is really nothing to distinguish the two implants in terms of severe adverse events. Unlike ASR, J&J voluntarily discontinued the Pinnacle Metal on Metal implant. Therefore, they escaped the brunt of regulatory scrutiny. And the government is well aware of this implant being faulty but continues to remain silent.”
Read more from The Indian Express’ investigation series ‘Implant Files’
