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The Maharashtra Food and Drug Administration (FDA) has forwarded applications of at least 50 patients for compensation after they underwent hip implants manufactured by pharmaceutical giant Johnson & Johnson (J&J) and suffered side effects.
The state government has so far received 74 applications, of which it reviewed 68 applications sent by patients. FDA Commissioner Pallavi Darade said over a series of 11 meetings of specialists and FDA officials, 50 applications were found to be directly related with side effects pertaining to hip implants and have been forwarded to the central government. “It is an ongoing process. We will continue to receive applications,” Darade said.
In 2010, J&J had globally recalled articular surface replacement (ASR) implants after noticing adverse reaction in patients who underwent hip implant surgery. Among the most common adverse reaction was cobalt and chromium leaching from the metal implant into the blood stream, while some side effects were related to cancer. A Maharashtra FDA report in 2013 stated that at least 68 patients had suffered high Erythrocyte Sedimentation Rate (ESR), indicating poisoning in blood stream due to the hip implant.
Till 2010, subsidiary of J&J, DePuy Medical Private Limited, had imported 15,829 implants to India. Of those, 4,700 were used on patients who underwent the hip implant between 2006 and 2010 in India. Following the recall, only 1,295 medical devices were sent back. The central government has now begun processing the compensation component for these patients.
In Maharashtra, a five-member committee, including three doctors from JJ hospital, has been set up by the government to scrutinise each application for compensation. Officials said the compensation will be based on level of deformity caused by the implant. It may range between Rs 30 lakh to Rs 1.22 crore.
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