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Three patients buzz state FDA for faulty hip implants by J&J

Out of these,10 patients were suffering from severe pain.

Written by Tabassum Barnagarwala | Mumbai | Published: December 11, 2013 12:59:12 am

Following reports of pharmaceutical giant Johnson & Johnson agreeing to pay compensation of $2.5 billion to around 8,000 US citizens who had sued the company after being fit with faulty hip implants, the Maharashtra Food and Drug Administration (FDA) has received three complaints from Mumbai,Chennai and Hyderabad seeking help to get compensation for similar faulty hip implants.

As many as 4,700 Indians underwent faulty Articulate Surface Replacement (ASR) implants manufactured by DePuy Medical Private Limited (DMPL),a subsidiary of Johnson & Johnson,but very few are aware of the poisonous effects of the implant. While the company had recalled its implants from USA,Europe and Australia,it called for a recall in India late in 2010. Till then,DePuy had imported 15,829 implants in the country out of which only 1,295 medical devices were sent back,confirmed FDA authorities.

Out of the 4,700 people who underwent the ASR implant,only 280 have registered a complaint with the company and 68 patients said they needed a revision surgery. Out of these,10 patients were suffering from severe pain.

Following an anonymous complaint in March 2011,the FDA registered an FIR against the company under section 328 (causing grievous hurt) of the IPC and sections of the Drugs and Cosmetics Act against DMPL for importing and marketing the implants in India despite recalling the product in several other countries.

In the past week,three patients have contacted the Maharashtra FDA. “Out of those who approached us,one resident is from Mumbai and two other are from Chennai and Hyderabad. We have asked them to furnish all documents related to the surgery,” said FDA joint commissioner Madhuri Pawar.

According to a 39-year-old Chennai-based patient,while the company has agreed to pay close to Rs 1.2 crore each to US patients,an Indian will have to be satisfied by a sum in lakhs. The patient,who approached Puri & Crawford — a company appointed by DePuy to assist patients for compensation,was told that a reimbursement will comprise ‘coverage of customary and reasonable expenses during the surgery’. “I was indirectly told that if I was unhappy with the compensation,I can fight it in court,” he said.

When contacted regarding the complaints registered with the FDA,a DePuy spokesperson said,“DePuy is committed to addressing reasonable and customary costs of testing and treatment for reasons related to the recall,including revision surgery if necessary and advised by the surgeon. DePuy will also pay for reasonable expenses related to receiving care,such as lost wages and travel costs.”

With word spreading slowly,hip implant patients experiencing leg pain,difficulty in walking and inability to bear weight have started realising the existence of metal deposits in their joints. The ASR implants led to ‘leaching of cobalt and chromium ions into the body system which has caused high metal toxicity and pain in legs’,according to the FDA. The Chennai-based patient said,“I underwent hip implant thrice (2005,2006 and 2008). The ASR implant had dislodged itself and was cutting into my bone. After a lot of research I realised that a similar scenario is prevailing across the globe.”

“In Australia,the revision surgeries rose to 13 per cent which forced Johnson & Johnson to recall the implants. Since there were no complaints from patients in India,they did not take a similar decision,” Pawar said. Despite sending two complaints to DePuy in 2011,no immediate action was taken,she added.

“According to our research,all the 68 patients have high ESR (erythrocyte sedimentation rate) value which confirms poisoning,” Pawar said. ESR is a common hematology test to measure inflammation.

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