Maharashtra Food and Drug Administration (FDA) has recommended the state Home department to handover the case related to Johnson & Johnson Ltd subsidiary De Puy Orthopaedics Inc.'s 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 is 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.

The state FDA had filed an FIR at Mahim Police station against the company on the grounds that it had not taken proper remedial measures to inform patients 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.

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 documents submitted by the company to the state FDA, it was found that out of 280 patients 68 patients required revision surgery (25 per cent). Out of these 68 patients, 63 patients were suffering from pain and 10 patients were suffering from various painful conditions like difficulty in walking, component loosening and inability to bear weight.

Taking cognizance of the fact that the product had been recalled in the US, UK and Australia, Maharashtra FDA initiated probe and filed the 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. The company has been booked under section 328 of Indian Penal Code and Section 17 (A),(E) & 18 (A) (1), 27 (A) of Drugs and Cosmetics Act 1940 and Rules 1945.

In response to the inapt product recall of defective medical device – ASR hip replacement Implants in India and hence endangering patient safety, Drugs Controller General of India (DCGI) has also canceled import license and registration certificate of Johnson & Johnson subsidiary De Puy Orthopaedics Inc.

Informed Madhuri Pawar, assistant commissioner, Maharashtra State FDA, "Patients who had undergone the hip replacement surgery using ASR implants and are suffering because of related symptoms can approach the State FDA headquarters or concerned police station for further guidance regarding compensation."