New Delhi: Indian victims of “faulty" hip implants sold by healthcare giant Johnson and Johnson (J&J) may get as much as ₹ 1.2 crore each in compensation, according to a formula devised by a government panel of experts. The formula has to be approved by the health ministry, two people aware of the development said, requesting anonymity.
The minimum compensation in case of a disability will be ₹ 33 lakh, according to the formula that is based on the percentage of disability and age, the people said. “The compensation amount is expected to vary from ₹ 33 lakh to ₹ 1.2 crore," they said.
The expert committee that met on Wednesday also recommended the use of the Indian Disability Evaluation and Assessment Scale (IDEAS) for the assessment and certification of disability in patients.
“In case the disability is on the higher scale (40-45%) and the person underwent the hip surgery at a young age and is suffering, the quantum of compensation will go up," said one of the two people cited above.
“The compensation will keep up with the cost of living in the future, disturbance of routine and mental agony," the second person said. “So, if a person underwent a surgery when he/she was 60 years or above and the disability is measured at the scale of 10%, he/she will be entitled to get a minimum of ₹ 33 lakh."
Once the health ministry approves the formula, the process of compensation will start, the second person said. This will be the first-ever instance of compensation being paid for substandard treatment in the country.
Around 100 people fitted with J&J’s Acetabular Surface Replacement (ASR) hip implant have already approached the committee for compensation.
Anyone suffering from faulty hip implants could apply for compensation and not just those who underwent revision surgeries, the chairman of the central expert committee had said earlier.
Patients claiming compensation are required to fill in a form published on the drug regulator’s website. Other than sharing some personal details, the patients are supposed to mention the date of the first surgery, the type of surgery, the 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 the medical symptoms arising out of the use of the ASR implant.
The central expert committee examined the existing Acts such as the Motor Vehicles Act and the rules for injuries or deaths from clinical trials in India to arrive at the formula for determining the quantum of damages.
J&J has been criticized for failing to pay any compensation in India, although it had agreed to pay hefty damages of $2.5 billion to around 8,000 US citizens, who sued the company after receiving the faulty hip implants.
Around 4,700 ASR surgeries were carried out in India between 2004 and 2010. However, only 1,080 patients could be traced through the ASR helpline.
There are currently no specific legal provisions to provide compensation to patients.
A top J&J executive said 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," said Sushobhan Dasgupta, managing director, J&J Medical India and vice president (orthopaedics) for Asia Pacific, in an interview.