New Delhi: A central expert committee formed by the health ministry to decide on compensation for patients affected by ‘faulty’ hip implants of Johnson and Johnson (J&J) is examining compensation provisions under the Motor Vehicles Act and rules for injuries or deaths from clinical trials in India to arrive at a formula for determining the quantum of damages, said two people aware of the matter.

This will be the first-ever initiative of compensation being paid for sub-standard treatment in the country. “The team of experts is looking at every angle so that patients can benefit the most. Since 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 the first person cited above dispelling speculation that the committee is looking at the protocol set by other countries where the company has already paid compensation. “The compensation procedure used in the US and Australia cannot be applied in India," the person said.

Ironically, under the Motor Vehicles Act, the amount of compensation payable in case of death is a meagre 5 lakh. The minimum compensation in case of permanent disability of any kind shall not be less than 50,000. However, for accidents resulting in minor injuries, the compensation amount is fixed at 25,000.

The Acetabular Surface Replacement (ASR) or hip implant known as DePuy ASR was sold in India by DePuy International, a unit of J&J and has come under severe scrutiny of government agencies after a Mint investigation published on 23 August brought out the ordeal of patients and highlighted the negligence of the US-based company.

So far, more than 30 patients have approached the committee formed on 11 September under the chairmanship of Dr R.K. Arya, head, sports injury centre, Safdarjung hospital. The committee met on Monday and is likely to finalize the formula in its next meeting slated for 8 October.

There are currently no specific legal provisions to provide compensation to patients. Patients who want to claim compensation are required to fill in a form published on the drug regulator’s website, sharing their personal details, date of first surgery, type of surgery, identification number of the ASR hip implanted, 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, medical symptoms caused due to use of ASR implant, among other details.

“Based on the documents submitted by the patients, they will be called and referred to the government hospitals to examine the extent of damage," the second person said.

J&J has been in the dock for adopting double standards by not paying any compensation in India so far contrary to a hefty compensation of $2.5 billion that it agreed to pay to around 8,000 US citizens who sued the company after the faulty hip implants.

The affected patients say that compensation should be based on physical, mental, social and economic harm faced by patients. “Not only the basis of physical medical criteria. It is critically important that patients, their representatives and a psychologist are part of the committee and their voices should be heard," said Kabbir Chandhok, who had an ASR implant and continues to suffer from severe complications after multiple revision surgeries

Around 4,700 ASR surgeries were carried out in India between 2004 and 2010, only 1,080 patients could be traced through the ASR helpline.

On their part, a top J&J executive said earlier in September that they will 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.

Close