Multinational pharma major Johnson & Johnson (J&J ) is in the eye of a rising storm for double standards in compensation payouts to patients in the US and India who used its faulty metal-on-metal Articular Surface Replacement (ASR) hip implant. J&J’s DePuy Orthopaedics unit recalled its ASR systems from markets around the world in August 2010 after reports of high failure rates and pain and inflammation from metal toxicity. Since then, the company has agreed to pay $4.4 billion to patients following lawsuits in the US.
Marketed as more durable than existing implants, the metal-on-metal hip replacement systems ended up releasing microscopic amounts of metal ions, which led to bone damage and tissue death from metallosis (metal poisoning). More than 11,000 lawsuits are still pending in the US even as more are being filed, according to Drugwatch, a US-based not for profit patient-enabling group. Close to 4,700 people received the faulty implant in India before the recall, but only 1,080 have been tracked. Of them, only 275 underwent revision surgeries, while the others are being monitored for side effects. With the manufacturer, orthopaedic surgeons and hospitals making little effort to reach out to them, more than 3,600 patients have slipped through the cracks and continue to live in pain.
A health ministry committee set up in February 2017 to examine complaints from patients said J&J “suppressed” information on the side effects. Mumbai-based ASR hip recipient Vijay Vojhala had to haggle with J&J for two years before it agreed to foot the bill for a revision surgery in 2012. By then, metal toxicity led to the then 40-year-old to lose teeth, hearing in his right ear, his job, and his ability to walk without pain, all because the omerta code between big pharma, hospitals and doctors in India. The health ministry committee has recommended Rs 20 lakh as compensation, which is a fraction of the US $247 million paid out to six patients in Dallas in November last year. It took Vojhala, a medical representative who worked with orthopaedic surgeons, two years of pain before he heard about the recall and realised he could seek compensation. Now he and a dozen other patients like him who have suffered are considering a class action suit against J&J demanding matching compensation.
{{/usCountry}}A health ministry committee set up in February 2017 to examine complaints from patients said J&J “suppressed” information on the side effects. Mumbai-based ASR hip recipient Vijay Vojhala had to haggle with J&J for two years before it agreed to foot the bill for a revision surgery in 2012. By then, metal toxicity led to the then 40-year-old to lose teeth, hearing in his right ear, his job, and his ability to walk without pain, all because the omerta code between big pharma, hospitals and doctors in India. The health ministry committee has recommended Rs 20 lakh as compensation, which is a fraction of the US $247 million paid out to six patients in Dallas in November last year. It took Vojhala, a medical representative who worked with orthopaedic surgeons, two years of pain before he heard about the recall and realised he could seek compensation. Now he and a dozen other patients like him who have suffered are considering a class action suit against J&J demanding matching compensation.
{{/usCountry}}Even as that happens, the government must make sharing information on drug and device recalls transparent and institutionalise adverse drug reaction reporting to ensure patients in India are empowered and treated on par with those elsewhere.