New Delhi: Patients with Johnson and Johnson’s (J&J) controversial hip implant have raised objections to the compensation package proposed by the Central government.
Over 50 patients with the ‘articular surface replacement’ (ASR) hip implant have written to the government’s expert committee looking into the matter, according to a report in the Indian Express.
In their letter, they have listed their objections over how the government has proposed to calculate what compensations the company should pay different patients. Three of their objections are explained.
Last year, the government proposed that all affected patients could receive compensation between Rs 33 lakh and Rs 1.22 crore. In January, the Supreme Court accepted this compensation plan and told the government to advertise it widely.
But the amounts of Rs 33 lakh and Rs 1.22 crore was apparently reached based on how compensation for clinical trials are calculated in India.
In their letter, the patients reason that “In a clinical trial, there is a certain presumption of risk because the drug is under study for safety and efficacy.” But victims of the J&J implant did not have the same risks to consider as the device was approved for commercial sale by Indian authorities – so patients obviously assumed the device was safe.
Here, “the harm caused to patients was a result of negligence,” they say and not due to unknown risks of new drugs as in a trial.
Secondly, the government has also said patients should produce a disability certificate while applying for compensation. But with the ASR implants, patients have been suffering from metal ion poisoning, which is one of the reasons why they have found the implants problematic.
However, Indian authorities do not issue disability certificates for this kind of poisoning.
A third problem patients have with the compensation package is that the formula considers them similar to terminally-ill patients. In their letter, patients have disagreed with this characterisation. They say that terminally-ill patients are those with high risk and an expected survival of only a few years or months.
Whereas, here, the patients may live for years with several surgeries and a lot of pain.
J&J pays compensation abroad but not in India
The government studied the Motor Vehicles Act and the procedure to compensate clinical trial victims while coming up with the formula. They also invited all patients suffering from these implants to apply for compensation and not just those who have had revision surgeries.
In 2017, an expert committee in the health ministry suggested that all patients be paid a base amount of at least Rs 20 lakh.
Then, last November, the government finalised a formula for compensation. By this formula, patients could be eligible for anything between Rs 20 lakh to Rs 1.22 crore, with an additional Rs 10 lakh for non-pecuniary damages. The amount of compensation would be determined depending on the victim’s age, disability and other risk factors. The basic amount was later hiked to Rs 33 lakh.
Johnson and Johnson in India have said they will work alongside the government on providing redressal to patients but they have been resisting paying any compensation.
This even though the company agreed to pay $2.5 billion to around 8,000 US citizens as compensation in 2013. The amount was paid after their implants were globally recalled in August 2010 by the US government. Last November, a federal jury in Dallas also ordered J&J to pay $247 million to six patients over hip implants.
In India, J&J has moved the Delhi high court against the compensation plan. Their effort has been somewhat stymied by the fact that the Supreme Court is also hearing a public interest litigation against the company initiated by affected patients.
J&J has also proposed its own compensation programme. In it they say they may provide support to patients who have been implanted between June 2004 and August 2010, and if the revision surgery has taken pace within 15 years from the date of the actual hip replacement surgery. They plan to end their programme by 2025.