Man appeals to PM over faulty hip implant
A 42-year-old Dombivli resident, who was fitted with a Johnson & Johnson hip implant that was recalled worldwide in 2010, has written to Prime Minister Narendra Modi, demanding his intervention in seeking compensation from the US pharma giant.
In 2008, Vijay Vojhala was fitted with a metal-on-metal articular surface replacement (ASR) hip implant manufactured by J&J subsidiary DePuy Orthopaedics. However, the ASR led to severe metal deposition in his body, eventually requiring him to undergo revision surgery in 2012.
In his letter to the prime minister's office, Vojhala pointed out that J&J paid huge compensation to patients in US, but Indian patients are left in the lurch as no agency followed up the matter.
“Food and Drug Administration filed a complaint with Mahim Police Station. The FIR was registered in 2011, but no investigations were carried out and no charge sheet filed,“ said Vojhala, who suffers from avascular necrosis, a condition that results when bones do not get enough blood due to which he was advised hip replacement surgery.
Following the 2008 surgery at Hurkisondas Hospital, Vojhala had to give up his job in a multinational company due to low performance.“Post-surgery I was in continuous pain and my hip made a squeaking sound. But my surgeon assured me it was psychological,“ said Vojhala.
It was only in 2011 while attending an orthopaedic conference in Nagpur that he learnt something was wrong. “I got to know only then that the implant was recalled globally,“ he said.
Vojhala followed up with the ASR helpline, and tests revealed high levels of cobalt and chromium deposits in his body, one of the reasons for the implants being recalled. The ASR approved fully funded revision surgery for Vojhala, which was done at Breach Candy Hospital in 2012.
“After that, I got back to work, but had lost confidence, my morale and contacts. My body had given up and I constantly suffered pain and cramps,“ said Vojhala. He now wants J&J to compensate him for his suffering. “There are thousands suffering like me, we need justice.“
In US, over 8,000 litigants were compensated by over Rs 15,000 crore, but not so in India due to low awareness about the product recall. Former FDA commissioner Mahesh Zagade took up the task by filing the 2011 FIR, but no progress was made.
When Mumbai Mirror contacted current FDA commissioner HS Kamble, he said, “We are following up the case rigorously and will provide con crete information in a fortnight.“
A J&J spokesperson said they received a query from Drug Controller General of India referring to Vojhala's case.
“We responded to the letter,“ the spokesperson said, adding that in India 936 patients registered with ASR helpline, 184 underwent revision surgery, and the rest are under monitoring.
“Not all ASR patients require revision surgery, and a number of them are doing well. Some have moved court and the matter is sub-judice.Whenever an ASR patient seeks compensation, DePuy will assess facts and background with its legal advisors in India, and where appropriate, seek to reach a reasonable settlement,“ the spokesperson added.
While the spokesperson maintains that DePuy has been requesting surgeons to reach out to ASR patients, Vojhala was never informed about the same.
In 2008, Vijay Vojhala was fitted with a metal-on-metal articular surface replacement (ASR) hip implant manufactured by J&J subsidiary DePuy Orthopaedics. However, the ASR led to severe metal deposition in his body, eventually requiring him to undergo revision surgery in 2012.
In his letter to the prime minister's office, Vojhala pointed out that J&J paid huge compensation to patients in US, but Indian patients are left in the lurch as no agency followed up the matter.
“Food and Drug Administration filed a complaint with Mahim Police Station. The FIR was registered in 2011, but no investigations were carried out and no charge sheet filed,“ said Vojhala, who suffers from avascular necrosis, a condition that results when bones do not get enough blood due to which he was advised hip replacement surgery.
Following the 2008 surgery at Hurkisondas Hospital, Vojhala had to give up his job in a multinational company due to low performance.“Post-surgery I was in continuous pain and my hip made a squeaking sound. But my surgeon assured me it was psychological,“ said Vojhala.
It was only in 2011 while attending an orthopaedic conference in Nagpur that he learnt something was wrong. “I got to know only then that the implant was recalled globally,“ he said.
Vojhala followed up with the ASR helpline, and tests revealed high levels of cobalt and chromium deposits in his body, one of the reasons for the implants being recalled. The ASR approved fully funded revision surgery for Vojhala, which was done at Breach Candy Hospital in 2012.
“After that, I got back to work, but had lost confidence, my morale and contacts. My body had given up and I constantly suffered pain and cramps,“ said Vojhala. He now wants J&J to compensate him for his suffering. “There are thousands suffering like me, we need justice.“
In US, over 8,000 litigants were compensated by over Rs 15,000 crore, but not so in India due to low awareness about the product recall. Former FDA commissioner Mahesh Zagade took up the task by filing the 2011 FIR, but no progress was made.
When Mumbai Mirror contacted current FDA commissioner HS Kamble, he said, “We are following up the case rigorously and will provide con crete information in a fortnight.“
A J&J spokesperson said they received a query from Drug Controller General of India referring to Vojhala's case.
“We responded to the letter,“ the spokesperson said, adding that in India 936 patients registered with ASR helpline, 184 underwent revision surgery, and the rest are under monitoring.
“Not all ASR patients require revision surgery, and a number of them are doing well. Some have moved court and the matter is sub-judice.Whenever an ASR patient seeks compensation, DePuy will assess facts and background with its legal advisors in India, and where appropriate, seek to reach a reasonable settlement,“ the spokesperson added.
While the spokesperson maintains that DePuy has been requesting surgeons to reach out to ASR patients, Vojhala was never informed about the same.
