The Centre on Wednesday said it was the responsibility of Johnson & Johnson to compensate all the patients who reported adverse reactions to “faulty” hip implants manufactured by a company subsidiary and underwent revision surgeries, PTI reported. The health ministry directed the firm to comply with all the recommendations of an expert panel.
In its order to Johnson & Johnson, the ministry said the rest of the patients who have received articular surface replacement should be traced and covered under the company’s reimbursement programmes until 2025. The company had initiated the programmes across the globe in 2010 to conduct revision surgeries. In India, the revision surgeries started only in 2013.
A report published by an expert committee that the Union Ministry of Health and Family Welfare had set up showed that over 3,600 patients with the faulty implants were untraceable, and at least four people had died after undergoing surgery to implant the devices.
The ministry asked the company to reach out to the patients who have received the implants through advertisements. It asked Johnson & Johnson to issue a suitable advisory from time to time that will “provide recommendations to orthopaedic surgeons for patient’s management including regular follow-up”.
“The firm should be made liable to pay adequate compensation commensurate with severity of the pain, the resultant disability sufferings [both mental & physical] and with the loss of wages of each of the patients who had received ASR,” the order read.
The case
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.
The hip implant devices, called articular surface replacement or 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. Following red flags after rising revision surgeries, the firm recalled the devices on August 24, 2010.