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State FDA to expedite compensation process in defective medical device recall case

Shardul Nautiyal, Mumbai
Thursday, May 28, 2015, 08:00 Hrs  [IST]

Against the backdrop of compensation related issues relating to inappropriate recall of metal-on-metal articular surface replacement (ASR) hip replacement implants in India, the Maharashtra Food and Drug Administration (FDA) is planning to expedite the process of compensating the patients in a timely manner. The state regulator has recently held discussions with the Johnson & Johnson Ltd subsidiary De Puy Orthopaedics Inc officials on the same.  

The state 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 recent 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.

Over 4500 ASR Hip implant surgeries were performed in India using these defective implants from May 2004 to August 2010 before the product recall.

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.

As per company officials, in India 936 patients are registered with ASR helpline, 184 underwent revision surgery, and the rest are under monitoring.

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.


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