The government has sent Johnson & Johnson the formula devised to compensate patients for the faulty hip implants. The firm has sought some time to respond.
New Delhi: American pharmaceutical major Johnson & Johnson is expected to cough up a compensation of Rs 30 lakh to Rs 1.2 crore to Indian patients who suffered injury from its faulty hip implants.
The Central Drugs Standard Control Organisation (CDSCO), a drug and medical device regulation body under the Ministry of Health and Family Welfare, has sent J&J the formula devised by an expert panel to calculate the compensation. The formula is based on a patient’s age and the level of disability introduced by the devices.
The letter was dispatched after the CDSCO last week approved monetary compensation for the patients affected. Johnson & Johnson has sought seven to 10 days to study the formula and get back to the government.
“We have communicated the formula to Johnson & Johnson and they have requested for some time before they start reimbursements,” S. Eswara Reddy, the drug controller general of India (the apex health regulator who heads CDSCO), told ThePrint.
Once J&J accepts the formula, the company will be directed to pay patients compensation amounts ranging between Rs 30 lakh and Rs 1.2 crore. And it will have to pay the compensation decided, Reddy had told ThePrint earlier.
In October, Reddy had said the company had “put in writing” that it will pay the compensation decided by the Health Ministry-constituted expert committee examining the issue.
“The company will not have a choice of rejecting the decided compensation and we have it in writing,” Reddy had said.
ThePrint reached J&J for comment but the company is yet to respond. However, earlier, the company’s spokesperson had told ThePrint that it “will respect the (expert) committee’s decision” on the quantum of compensation.
Meanwhile, the government has started vetting the applications of Indian recipients of the implants to decide who is eligible for compensation, and expects more patients to come forward.
“So far, there are 150 patients whose applications are being scrutinised by the expert committee, Reddy said. “However, the enrolments are likely to go up in the coming weeks.”
The $2.5 billion US payout
India began to import the Articular Surface Replacement (ASR) hip implants in 2004, through a J&J subsidiary. By 2010, when J&J ordered its global recall, the faulty equipment had been used in around 4,700 surgeries in India.
In 2013, the company reached a $2.5 billion settlement with thousands of American patients who sued it over the implants.
According to a Reuters report from that time, metal hip implant systems, like the one imported from the J&J subsidiary, “were designed to be more durable, replacing a traditional metal-on-plastic ball-and-socket design. Instead, some patients who received the ASR hips reported experiencing pain, swelling, joint dislocation and sometimes damage to the central nervous system, thyroid and heart”.
The compensation was meant for the estimated 8,000 American patients who had to undergo further surgery to replace the faulty systems, The New York Times had reported.
The NYT report had referred to the devices as “as one of the most-flawed medical implants sold in recent decades”.
“The DePuy Orthopaedics division of Johnson & Johnson estimated in an internal document in 2011 that the device would fail within five years in 40 per cent of the patients who received it,” the report had stated.
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