New Delhi: The Modi government Sunday announced that it has directed American device maker, Johnson & Johnson, to pay over Rs 74 lakh to a victim of the company’s faulty hip implants.
This is the first time that a patient will be compensated for the faulty ASR (Articular Surface Replacement) hip implant used in India between 2004 and 2010. Surgeries were conducted on as many as 4700 people in India before J&J recalled the implants globally.
The government released its statement just an hour before the Election Commission of India announced the poll schedule for the 2019 Lok Sabha elections.
“The state-level committee had forwarded its recommendation to the central expert committee along with various documents including the disability certificate issued by the medical authority for necessary actions,” said the statement released by the Central Drugs Standard Control Organisation (CDSCO), a national regulatory body for pharmaceuticals and medical devices.
The government’s statement has further clarified that the central expert committee met on Friday, 8 March, and had examined the recommendation.
It stated that it was then decided that the patient implanted with faulty ASR hip implant (on both hips and subsequent revision of left hip), is entitled to the financial compensation as per the formula that the government had announced in October 2018.
“The government has issued the direction to Johnson & Johnson to pay the sum of Rs 74,57,180 within the period of 30 days from the date of receipt of the order as compensation amount to the patient and submit a copy of acknowledgment from the patient about the compensation paid to the CDSCO within the said period,” said the statement.
Johnson & Johnson refused to comment on the development.
“As this matter is sub-judice, we are unable to provide a comment,” a company spokesperson said through text message.
Patients too are unsure as to what to make of the development. “It is difficult to comment anything unless we know the full details,” said Vijay Vojhala, a patient who has been at the forefront of the fight against the company.
Johnson & Johnson had moved court
The US pharmaceutical giant had, however, approached the Delhi High Court in December, challenging the government’s compensation formula deciding the quantum of penalty. Repeatedly, the company has emphasised that Indian laws do not contain any compensation provision.
ThePrint, which first accessed the petition filed by the company, had reported that the company has termed the actions of Modi government as being “absolutely one-sided” and “liable to be rejected”.
“The compensation formula contained is derived from legislation that is not the law as on date,” the petition said.
J&J’s ‘written commitment’
While the company remained non-committal on the payment of the penalty to the patients, the government had claimed that the company has put it “in writing”.
Eswara Reddy, the drug controller general of India (DCGI), the apex health regulator, had told ThePrint earlier that J&J has “put in writing” that it will pay compensation as decided by an expert committee examining the issue. “The company will not have a choice of rejecting the decided compensation and we have it in writing. The minimum amount of compensation is Rs 20 lakh,” Reddy had said.