Everybody who is suffering due to Johnson and Johnson's Acetabular Surface Replacement (ASR) is eligible to apply for compensation, and is not limited to those who underwent revision surgeries
New Delhi: Anyone suffering from faulty hip implants by pharma giant Johnson and Johnson Pvt. Ltd (J&J) can apply for compensation, and not just those who have undergone revision surgery, the chairman of the central expert committee on the matter said on Monday.
Around 100 people fitted with J&J’s Acetabular Surface Replacement (ASR) hip implant have already approached the committee, formed by the government to work on compensation for aggrieved patients.
“Everybody who is suffering due to ASR is eligible to apply for compensation. It is not limited to those who underwent revision surgeries," the committee head, Dr R.K. Arya, said. “The committee will take the final decision, based on the documents that are submitted by the patients. The extent of damage will be examined and thereafter the compensation will be decided."
Patients claiming compensation are required to fill in a form published on the website of the drug regulator, Central Drugs Standard Control Organization. Other than sharing their personal details, the patients would be required to furnish information such as the date of the first surgery, type of surgery, identification number of the ASR hip implant, details of revision surgery, if the patient has received any medical management by the company, if any compensation other than the reimbursement has been paid by the company and medical symptoms caused by the ASR implant.
The ASR hip implant known as DePuy ASR was sold in India by DePuy International, a unit of J&J.
To arrive at the formula for determining the quantum of damages, the central expert committee has been examining all other provisions such as the Motor Vehicles Act and Rules for compensation for injuries or deaths from clinical trials in India. A legal expert has also been co-opted in the committee, which met on Monday to discuss the pros and cons of the available methods of determining compensation.
“We are working on the references that are available in India. The formula will be legally vetted by the expert. The idea is to adopt the most simple, easy and legally acceptable formula and that is why we are taking time," Arya said.
This will be the first-ever instance of compensation being paid for substandard treatment in India. “The team of experts is looking at every angle so that patients can benefit the most. As this is happening for the first time in India, they are examining all other existing rules and provisions in the Motor Vehicles Act and clinical trial rules to finalize a protocol for this case," said a senior official on condition of anonymity. The official added that the committee would meet again next week when it is likely to decide on the formula for compensation.
J&J has been in the dock over double standards for failing to pay compensation in India, in contrast to the hefty compensation of $2.5 billion that it has agreed to pay to around 8,000 US citizens, who sued the firm for faulty hip implants. The Supreme Court on Friday sought the views of the expert panel on the J&J hip implants, directing it to file its report in two months.
Affected patients say that compensation should be based on physical, mental, social and economic harm. Around 4,700 ASR surgeries were carried out in India between 2004 and 2010, though only 1,080 patients have been traced through the ASR helpline.
There are currently no specific legal provisions to provide compensation to patients.
On J&J’s part, a top executive said earlier in September that the company would work out a compensation plan with the Indian government for patients affected by the hip implants.
“The company would like to work with the expert committee and try and see what is the best way forward to be able to ensure that patients who require certain amounts of money as compensation... is fair, equitable and adequate...which is right for the patients. Because we will be taking care of the patients and that’s for sure and that’s the reason we would like to work with the government," Sushobhan Dasgupta, managing director, J&J medical India and vice president (orthopaedics) for Asia Pacific, said in an interview last month.
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