There are currently no specific legal provisions in India to provide compensation to patients
In what could set a precedent, Indian patients who received faulty hip implants sold by Johnson and Johnson (J&J) may get a compensation of between Rs 30 lakh and Rs 1.22 crore, depending on factors like age and disability, according to a formula approved by the government.
According to the government's formula, the minimum base amount of compensation is fixed at Rs 20 lakh, in addition to Rs 10 lakh as non-pecuniary damages. The base amount rises with factors such as age and extent of disability.
For instance, a 50-year-old person with a disability percentage of 50 or more may get a compensation of around Rs 60 lakh.
Patients implanted with faulty Articular Surface Replace (ASR) hip implants before August 2010 will be eligible for compensation.
There are currently no specific legal provisions to provide compensation to patients. This will be the first-ever instance of compensation being paid for implanting a substandard product in the country.
J&J in September said the company would work out a compensation plan with the Indian government for patients who suffered because of its artificial hip implants.
So far, around 100 patients have got in touch with the government for the compensation.
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 faulty hip implants.
Around 4,700 ASR surgeries were carried out in India between 2004 and 2010, according to J&J. However, only 1,080 patients could be traced through the ASR helpline.
After receiving several complaints from patients, the government formed an expert panel under the chairmanship of Arun Kumar, Ex-Dean and Professor of ENT at Maulana Azad Medical College in New Delhi, to examine the issues pertaining to faulty ASR hip implants.
The committee, after a detailed examination of the issues, submitted its report along with its final recommendations, based on which the government constituted a Central Expert Committee headed by RK Arya, Director at Sports Injury Centre, to determine the quantum of compensation.
"We are glad that Government has listened to patients angst and concerns - this formula will send a new benchmark internationally and though loss of life or disability can never be truly compensated to a troubled patient yet frankly this will be financially a tall order for any manufacturer to service and this will open up the insurance sector for product liability insurance in India," said Rajiv Nath, Forum Coordinator, AiMeD, which represents domestic medical device companies.
