Recalling a medical device is not like recalling a consumer product from the market.
In 2010, DePuy Orthopedics, a subsidiary of the pharma major Johnson and Johnson, recalled ASR, a hip replacement system it had placed in the global market in 2005. The company described the move as “voluntary recall”. However, according to the British Medical Journal, the Australian Joint Registry had warned DePuy more than “17 times between 2007 and 2009 about the problems with ASR”. Studies in the UK had also highlighted problems with the hip replacement device. More than eight years later, an expert committee of the Union Ministry of Health and Family Welfare (MoHFW) has revealed the magnitude of the problem in India. The committee’s report shines a light on regulatory failure in monitoring implant patients in the country. It states that over 3,600 patients with faulty ASR implants remain untraceable, and “at least four deaths have been reported from those who underwent surgeries to use these devices”.
Recalling a medical device is not like recalling a consumer product from the market. Defective implants cause pain — and in the case of ASR, even death. Patients who had paid Rs 3.5-5 lakh for an implant they were told would support them for 15 years, found the device failing them in five to seven years. A mechanism to track the health of such patients, such as those in Australia and England, could have highlighted the gravity of the problem. The country did launch a project to create a database of joint replacement surgeries in 2007. But it would be another nine years before India would have its National Joint Replacement Registry. This was too late to record the ASR surgeries. The MoHFW expert committee report highlights the urgency of bringing patients with such implants into the ambit of this registry, even if retrospectively. It notes that “254 patients with ASR had to undergo a revision surgery after 2014. But the Central Drugs Standard Organisation has reports of only 48 such patients”.
In 2013, Johnson and Johnson agreed to pay more than $2.40 billion as compensation to around 8,000 patients who had received ASR. The MoHFW committee report notes that the company has not paid any compensation in India. It had recommended that Johnson and Johnson should pay at least 20 lakh to every affected patient. But it has been six months since the committee submitted its report and the government has not taken any action. The number of patients who undergo a joint replacement has been increasing by about 15 per cent since the past decade. The regulatory failure in the ASR case sends out the wrong message to patients, the medical community and the medical devices industry.