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State FDA to expedite compensation process in defective medical device recall case
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Shardul Nautiyal, Mumbai
May 28 , 2015
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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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