An 11-member committee set up by the health ministry in February came to the conclusion that Johnson and Johnson 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 Johnson and Johnson unit that sold the device in India, denied the allegation.
In total the committee had approached 101 patients, out of which 22 responded and stated that they had a revision surgery after the first surgery. Some of them underwent third surgery too.
On 16 November, the federal jury in Dallas ordered Johnson and Johnson and its DePuy Orthopaedics unit to pay $247 million to six patients. The jury found that the metal-on-metal 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. Johnson and Johnson won the first Pinnacle test trial in 2014, but subsequent juries determined the companies to be liable.
Johnson and Johnson 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. Johnson and Johnson, 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 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, 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 (FDA) 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 Johnson and Johnson 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.
“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 (DCGI) informed of all key actions and worked to provide Indian patients and surgeons with the information and support they need, in line with government requirements," the spokesperson added.
The first person cited above said the health ministry-appointed committee, headed by Arun Agarwal, former dean of the New Delhi-based Maulana Azad Medical College (MAMC), found that Johnson and Johnson had adopted a “callous approach" in dealing with Indian patients who had been reduced to an immobile life.
An email sent to the health ministry on Tuesday had not elicited any response as of press time on 19 November.
The DePuy spokesperson said the company’s “actions concerning the product were appropriate and responsible, and DePuy has fully 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."
“We will ensure that the full facts are presented and will vigorously defend the company and its actions," the spokesperson added.
The committee has concluded that a minimum compensation of Rs.20 lakh should be paid to each of the patients who had to undergo revision surgeries, the second person said. It also suggested the formation of regional committees.
“We have suggested that the affected patients may approach the regional committees, get their documents verified and based on the disability that the patients suffered due to the product, a further compensation may be decided by the committee," the second person said.
The committee is expected to submit its final report to the health ministry this month.
According to Ramesh Adige, a pharma industry expert and former executive director of Ranbaxy Laboratories Ltd, Johnson and Johnson was a “brand conscious" and “a responsible company" and that the committee must look into the Corrective Action and Preventive Action (CAPA) adopted by Johnson and Johnson.
“We must also check what are the extant laws in India which will address compensation to be given to patients who have had to undergo the pain and trauma of revision surgeries. Many must have lost their livelihoods. I presume Central Drugs Standard Control Organisation (CDSCO) will take cognizance of how the case found closure in US, Australia etc," Adige said.