The Central Consumer Forum (CCF) of National Consumer Disputes Redressal Commission (NCDRC) has served notices to the hospitals, doctors and company involved in delayed recall case of metal-on-metal ASR XL Acetabular Hip Replacement System (ASR) in India.
Over 4500 ASR Hip implant surgeries were performed in India using these defective implants from May 2004 to August 2010 before the product recall.
Patients impacted by its use have therefore also demanded that the amount of compensation should be equal or on par with what has been offered in the country of origin, USA, a case has been filed at CCF related to this recently.
Thousands of people across the US were implanted with DePuy Orthopaedic's defective ASR hip replacement system between 2005 and 2010, when it was finally recalled.
In August 2010, US-based Johnson & Johnson's subsidiary De Puy Orthopaedics Inc - a UK-based manufacturer issued a worldwide recall for the ASR XL Acetabular Hip Replacement System after data from the National Joint Registry of England and Wales showed that 1 out of every 8 patients (12 per cent-13 per cent) who had received the devices had to undergo revision surgery within five years of receiving it.
By then, more than 93,000 patients worldwide were fitted with an ASR hip implant. It is believed that roughly a third of those were patients in the US.
According to informed sources, "Patients have been adequately compensated in the US as per the law of the land and the same should be done in India as most of the patients are unaware of compensation related modalities. The company should take the onus of connecting with the patients as only a few patients out of over 4000 patients impacted by this device are registered with the company's helpline as of today."
As per sources, in India 936 patients are registered with ASR helpline, 184 underwent revision surgery, and the rest are under monitoring. Besides this, cases of revision surgeries have also increased upto 10 per cent.
Maharashtra Food and Drug Administration (FDA) had filed an FIR at Mahim police station in 2013 against De Puy Orthopaedics Inc on the grounds that it had not taken proper remedial measures to inform patients in India who had undergone ASR implant surgery. The recall was necessitated because of defectiveness of the subjected implant, its health implications and the inadequate compensation offered by the company for corrective action.
The state FDA had also recommended the state home department to handover the case of inappropriate recall of ASR Hip Replacement Implants in India to the Central Bureau of Investigation (CBI) for further investigation in the interest of over 4000 patients impacted by its use.
Recommendation for CBI probe was the fallout of Mumbai High Court's (HC) order dated October 14, 2013 in response to the writ petition filed by De Puy Orthopaedics Inc for quashing the FIR filed by the state FDA related to not properly recalling the defective hip replacement implant.
As per the HC order, the statements made by the company were not found correct and finally the company had to withdraw the case related to the quashing of FIR.
The company made the announcement of ASR implant recall on August 24, 2010 based on reports of pain in patients caused by release of cobalt and chromium ions used in the construction of this medical device. Around 8 to 9 per cent patients had to undergo revision surgery because of component loosening, fracture of bone and dislocation of the joint, as per the state FDA report.
Taking cognizance of the fact that the product had been recalled in the US, UK and Australia, Maharashtra FDA had initiated the probe and filed FIR against the company based on an anonymous complaint and further on not taking proper action in spite of several correspondence by FDA during 2011.