Johnson & Johnson may have to pay Indian patients for faulty implants

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New Delhi: Nearly seven years after US pharma giant Johnson & Johnson’s (J&J’s) hip replacement device was recalled in India in the wake of global reports of metal poisoning and high failure rate, many of those who underwent corrective surgery in the country due to the faulty device could soon be entitled to compensation.

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 orthopaedic 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.

A metal-on-metal articular surface replacement (ASR) hip implant device known as DePuy ASR was sold in India by DePuy International, a subsidiary of J&J, the world’s largest medical device company. 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 surgery.

In December 2016, a federal jury in Dallas ordered J&J and its DePuy Orthopaedics unit to pay more than $1 billion to six plaintiffs who said they were injured by their hip implants. In March 2015, it reportedly agreed to settle a second round of claims worth $420 million.

In 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.

A DePuy India spokesperson said the company’s priority has been “patient safety” and it has kept the Drug Controller General of India (DCGI) informed of all the actions it has taken.

“DePuy’s top priority is and always has been patient safety. We understand that the August 2010 ASR Hip System voluntary recall is concerning for patients, their family members and surgeons. Since the voluntary recall decision was made, DePuy has worked to provide patients and surgeons with the information and support they need, including an unprecedented reimbursement programme to address recall-related costs that was the first of its kind worldwide. We have kept the DCGI informed of all key actions and worked to provide Indian patients and surgeons with the information and support they need, in line with government requirements,” he said.

“DePuy’s actions concerning the product were appropriate and responsible, and DePuy has fully cooperated with the expert committee constituted by the Health ministry with respect to the ASR recall, and will continue to do so. We will ensure that the full facts are presented and will vigorously defend the company and its actions,” the spokesperson added.