Faulty hip implants: J&J may have to pay each patient ₹20 L in India
NEWDELHI: Johnson and Johnson (J&J) may be ordered to pay at least ₹20 lakh in compensation to each of the 22 Indian patients who were given allegedly faulty hip implants 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.
On November 16, the federal jury in Dallas ordered Johnson & Johnson and its DePuy Orthopaedics unit to pay $247 million to six patients. The jury found that the metal-onmetal hip implants were defectively designed and that the companies failed to warn consumers about the risks. Thursday’s verdict came in the fourth test trial over the devices in Dallas federal court, where some 9,000 of the cases are pending. J&J won the first Pinnacle test trial in 2014, but subsequent juries determined the companies to be liable.
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, the people cited above said. J&J, the world’s largest medical device maker, also paid compensation to patients in Australia and Canada, one of the persons cited above said.
The committee’s findings were based on submissions by 22 patients, all of whom had to undergo revision surgeries after being given the allegedly faulty implants, the panel found. Some of them told the panel 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, third person quoted above said.
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.
In August 2010, the US Food and Drug Administration issued a mandatory recall of the 93,000 so-called articular surface replacement (ASR) hip implant worldwide after authorities in the UK reported that 13% of patients given the implant ended up needing 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, one of the two person cited above 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. .. DePuy has cooperated with the expert committee constituted by the Ministry of Health and Family Welfare with respect to the ASR recall, and will continue to do so,” the spokesperson added.
An email sent to the health ministry on Tuesday had not elicited any response as of press time on November 19.