Mumbai: A week after the Bombay HC declined to quash the FIR against DePuy Medical Private Limited, a group company of Johnson & Johnson, FDA commissioner Mahesh Zagde has urged police commissioner Satya Pal Singh to appoint a special investigating officer to probe the charges against the firm.
“The HC has made it clear that the probe against the firm shall continue. The firm has implanted faulty medical devices. In USA and Europe, it has not only withdrawn the product, but also compensated the patients who had undergone surgery with faulty devices. In India, it has ignored most aggrieved patients. In view of seriousness of the case and also in larger public interest, a special investigation officer should be appointed,” Zagde said.
In a letter to Singh, Zagde pointed out that after it was confirmed that faulty devices had been implanted, it was the firm’s responsibility to recall the product, identify aggrieved patients and take necessary measures for a revision surgery. “Our information is that while 60% patients needed revision surgeries, no steps were taken to identify the patients. Under such circumstances, FDA can’t be a silent spectator. We stepped in and initiated criminal proceedings,” he said.
Further, Zagde said the firm has admitted that the devices were faulty and that it had recalled defective products across the world, but in India, it did not take adequate care to protect the safety of the patients. The firm has denied the charges, saying the FIR was an abuse of process of law and has resulted in a serious miscarriage of justice.
Courtesy:
Prafulla Marpakwar TNN
http://epaper.timesofindia.com/Default/Scripting/ArticleWin.asp?From=Archive&Source=Page&Skin=TOINEW&BaseHref=TOIM/2013/01/31&PageLabel=9&EntityId=Ar00901&ViewMode=HTML
“The HC has made it clear that the probe against the firm shall continue. The firm has implanted faulty medical devices. In USA and Europe, it has not only withdrawn the product, but also compensated the patients who had undergone surgery with faulty devices. In India, it has ignored most aggrieved patients. In view of seriousness of the case and also in larger public interest, a special investigation officer should be appointed,” Zagde said.
In a letter to Singh, Zagde pointed out that after it was confirmed that faulty devices had been implanted, it was the firm’s responsibility to recall the product, identify aggrieved patients and take necessary measures for a revision surgery. “Our information is that while 60% patients needed revision surgeries, no steps were taken to identify the patients. Under such circumstances, FDA can’t be a silent spectator. We stepped in and initiated criminal proceedings,” he said.
Further, Zagde said the firm has admitted that the devices were faulty and that it had recalled defective products across the world, but in India, it did not take adequate care to protect the safety of the patients. The firm has denied the charges, saying the FIR was an abuse of process of law and has resulted in a serious miscarriage of justice.
Courtesy:
Prafulla Marpakwar TNN
http://epaper.timesofindia.com/Default/Scripting/ArticleWin.asp?From=Archive&Source=Page&Skin=TOINEW&BaseHref=TOIM/2013/01/31&PageLabel=9&EntityId=Ar00901&ViewMode=HTML
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