J&J may have to compensate for faulty hip implants

The health ministry is reaching out to states following recommendations by an expert committee to compensate Indian patients who experienced adverse effects from hip implants imported and sold by Johnson & Johnson before 2010.The centre is asking states to set up their own committees for these patients to approach to claim damages from the company for problems like disabilities caused due to these implants, said two senior government officials directly aware of the development.
The state committees would process these complaints within two months of receiving them by examining "all" physical and clinical findings to understand the extent of disability the patient has suffered due to the implant, said one of the officials.

The committee would then submit its report to a central committee set up for this purpose, which will examine the findings and decide how much patients would be compensated before directing J&J to pay the patients.

The state committees will also have to reach out to hospitals to track any patients that could be suffering adverse reactions from these implants as the government does not expect every affected patient to come forward on their own.

According to the officials, the reason it has taken so long to arrive at this decision is because there is currently no provision to compensate patients for drugs and devices that are already approved in the market.
J&J, through subsidiary DePuy Orthopaedics, had issued a global recall of the implant system, called ASR Hip System, in 2010 after it received "new information" from the UK National Joint Registry, a J&J spokesperson said.

Reportedly over 4,500 patients in India had received this implant, and J&J is said to have reported over 100 serious adverse events to the Central Drugs Standard Control Organisation between 2014 and 2017.

The expert committee examining the issue had reportedly claimed that the company had hid key facts related to the potential harm from these implants and had recommended a minimum compensation of Rs 20 lakh for each patient affected.

The company is yet to receive the expert committee's report and said it would therefore be inappropriate for it to comment on the developments."We would like to reiterate that we have furnished full facts and data available with us to the expert committee," said the spokesperson.

"It is important to note that a voluntary recall doesn’t imply that the product is “faulty” nor does it imply that every patient who has received an ASR hip implant will necessarily have to undergo revision surgery. ASR continues to function well for many patients in India and around the world."

Throughout the history of the ASR implant, DePuy has maintained transparency and openness about how the design of the implant was tested and validated, the known risks associated with the ASR, and how the product has performed, the spokesperson added. ASR was imported and marketed in India "with all regulatory approval and permissions as were then applicable," the spokesperson told ET, adding that DePuy's actions concerning the product were "appropriate" and "responsible".

The company has since kept the Drugs Controller General of India, the country's apex drug regulator, informed of "all key actions" and has worked to provide Indian patients and surgeons with the information required, in line with government requirements, the spokesperson said.

"The expert committee is unequivocal in finding J&J guilty of deceit, medical negligence and willfully causing harm. The company should be criminally prosecuted," said Malini Aisola of patient activist group All India Drug Action Network.

"In this regard, the life of Indians should not be considered cheaper than Americans - relative to the billions of dollars that J&J has compensated victims in USA, the recommended 20 lakhs per patient is too less."