Faulty hip implants: Johnson and Johnson may be fined ₹20 lakh
NEWDELHI: Johnson and Johnson (J&J) may be ordered to pay as much as ₹20 lakh in compensation to each of the 22 Indian patients who were given faulty hip plants that required them to undergo revision surgeries, according to two people with knowledge of the matter.
An 11-member panel set up by the health ministry in February came to the conclusion that J&J was at fault for “serious medical negligence,” said the two people, both of whom serve on the panel, on condition of anonymity. A spokesperson for the local unit of DePuy International, the J&J unit that sold the device in India, denied the allegation.
J&J in 2013 agreed to pay $2.5 billion in compensation to around 8,000 US citizens who sued the company after being given the implants that were recalled globally in August 2010, but was non-committal about paying any damages to the Indian patients, they said. J&J, the world’s largest medical device maker, also paid compensation to patients in countries such as Australia and Canada, one of the persons cited above said.
The committee’s findings were based on submissions by 22 odd patients, all of them had to undergo revision surgeries after being given the faulty implants, the committee found. Some of them told the committee that they had to undergo a third surgery. The patients informed the panel that they suffered great pain and had to be confined to bed.
Case histories of the patients revealed that a flaw in the design of the implant led to an increase in chromium and cobalt levels in the body, which had a toxic effect on other parts of the body, endangering the lives of the patients, one of the two persons said. Many patients were confined to strict bed rest.
In August 2010, the US Food and Drug Administration issued a recall of the 93,000 articular surface replacement (ASR) hip implant globally after UK authorities reported that 13% of patients given the implant ended up needing a revision surgery.
The hip replacement device was recalled in India the same year.
The initial findings of the committee suggested that in India J&J had only provided reimbursement for recall-related revision surgeries, food and travel to the patients, but no compensation, another person privy to the details of the matter said.
DePuy’s reimbursement programme was intended to remove “financial barriers for patients so they could receive recall-related testing and treatment,” the company’s India spokesperson said in response to a detailed questionnaire. “The company’s decisions leading up to the voluntary recall of the ASR Hip System and subsequent actions, including a reimbursement programme for recall-related medical expenses, reflect our commitment to patients. DePuy acted properly and responsibly with respect to ASR, and we believe the full history of the product shows a company working to improve patients’ lives through innovation, taking action when necessary and standing by patients,” the spokesperson said.
“We have kept the Drugs Controller General of India informed of all key actions ,” the spokesperson added.
An email sent to the health ministry on Tuesday had not elicited any response till press time.