DePuy and its parent company Johnson & Johnson may be forced to deal with their product’s failures in India in the very near future. DePuy’s ASR hip replacement device not only injured people in the United States but affected people worldwide, including in India.
The DePuy hip replacement device was recalled in India seven years ago after reports of worldwide failures and injuries. The ministry of health and family welfare set up an expert committee two months ago, asking for a thorough investigation into the ordeal of those fitted with the defective hip implant. The committee is now on the verge of coming out with its report which is likely to seek compensation from J&J for the aggrieved patients, according to two government officials aware of the development.
The committee, headed by former dean of Maulana Azad Medical College (MAMC) Dr Arun K. Agarwal, has top orthopedic surgeons and legal experts in it. According to the people cited above, who spoke on condition of anonymity, the committee was mandated to suggest a relief mechanism for those who suffered due to the implant.
“In India, the device was implanted for people aged 50-60 years. The committee is collecting data from those who suffered pain and had loss of function due to the defective design of the device. All those who have suffered should get relief and are liable to be compensated,” said one of the two people.
The voluntary recall by the company started after the implant made of cobalt and chromium was found to be leaching metal into patients, leading to fluid accumulation and metal poisoning in some cases. Some patients required revision surgeries within five years of being implanted. In August 2010, the US Food and Drug Administration (FDA) issued a mandatory recall of 93,000 ASR implants worldwide after authorities in the UK reported that 13% of patients implanted with an ASR ended up needing revision sIn 2013, the Maharashtra Food and Drug Administration (FDA) filed an FIR at Mahim Police station against De Puy Orthopaedics Inc on the grounds that it had not taken proper remedial measures to inform patients in India who had undergone the implant surgery. At present over 14,000 J&J ASR devices are in use in India. A total of 1,080 patients have registered with a helpline set up by J&J, of whom 275 have undergone revision surgery in India.
The headaches have spread worldwide for the medical device company that disregarded patient safety concerns in favor of corporate profits. That’s what happens to companies that aren’t good corporate citizens in the USA and worldwide. DePuy and Johnson & Johnson are learning this lesson the hard way.