A central committee looking into compensation packages for patients who received faulty hip implants from Johnson and Johnson said it would not be limited only to those who underwent revision surgery, Mint reported on Tuesday. Around 100 people fitted with Acetabular Surface Replacement have approached the committee, said panel chairperson Dr RK Arya.
The hip implant devices, known as DePuy ASR, are manufactured by DePuy Orthopaedics Inc, a fully-owned subsidiary of Johnson & Johnson. In India, it is represented by Johnson & Johnson Private Ltd. The devices were first cleared by the United States Food and Drug Administration in 2005. After red flags were raised in the wake of rising revision surgeries, the firm recalled the devices on August 24, 2010.
The patients had to undergo revision surgeries due to severe pain in the hip, inability to walk, destruction of bone and deposition of harmful metal debris of the implant inside body tissue, according to medical device adverse reports of patients.
On October 5, the Supreme Court asked the Centre to respond to a petition alleging that more than 15,820 people have been fitted with faulty hip implants. The top court has also directed the government to submit the report of an expert committee looking into the matter.
“Everybody who is suffering due to ASR is eligible to apply for compensation,” Arya said, according to Mint. “It is not limited to those who underwent revision surgeries. The committee will take the final decision, based on the documents that are submitted by the patients. The extent of damage will be examined and thereafter the compensation will be decided.”
Those claiming compensation have to fill out a form available on Central Drugs Standard Control organisation’s website. This will be the first instance of a company paying compensation for substandard treatment in India, the newspaper reported. “We are working on the references that are available in India. The idea is to adopt the most simple, easy and legally acceptable formula and that is why we are taking time,” Arya said.
A health ministry report in 2017 reflected the company’s claim that 4,700 people had been fitted with the faulty implant, of whom only 882 had been traced. Over 3,600 patients with the faulty implants are now untraceable. At least four people died after undergoing surgery. The company itself has admitted that there were 121 “serious adverse events” related to the surgeries in India between January 2014 and June 2017. The government has said the company is responsible for paying damages to all patients who reported adverse reactions.
