Nearly three months after the Health Ministry approved a formula to compensate patients fitted with Johnson & Johnson’s controversial ASR hip implants in India, the national drug regulator has directed the medical device giant to pay a Maharashtra-based patient over Rs 74.5 lakh.
“This is the first case where M/s Johnson & Johnson has been directed to pay compensation for the Faulty ASR Hip Implant manufactured and imported by M/s DePuy International Limited (now Johnson & Johnson Pvt. Ltd.),” the Central Drugs Standard Control Organisation (CDSCO) said Sunday.
J&J is currently locked in a court battle against the government challenging the compensation formula, which would make patients eligible for amounts between Rs 30 lakh and Rs 1.23 crore, depending on their age and level of disability.
On March 8, a central expert committee to recommend compensation for these “faulty” hip implants examined an application of a patient from Maharashtra, the CDSCO stated Sunday.
“The Central Expert Committee after examining the documents as well as the recommendation of State Level Committee, is of the considered opinion that the patient implanted with faulty ASR Hip Implant on both hips and subsequent revision of left hip, is entitled for the financial compensation as per the formula,” it said.
“Based on the recommendations … CDSCO has issued direction on 08.03.2019 to M/s Johnson & Johnson Pvt Ltd to pay the sum of Rupees 74,57,180/-…within a period of 30 days from the date receipt of the order as compensation amount to the patient and submit a copy of acknowledgment from the patient about the compensation paid to CDSCO within the said period,” the CDSCO said.
J&J declined comment on the CDSCO directive.
The Indian Express first reported in August 2018 on the expert committee’s findings, that Johnson & Johnson “suppressed” key facts on the harmful aftermath of surgeries conducted on hundreds of patients in India using these hip replacement systems. The report, which was first submitted in February 2018, was not made public until August 2018.
Could set precedent for similar cases of compensation
Even while the CDSCO has ordered Johnson & Johnson to compensate a patient, the company has challenged the formula approved by the government to calculate the damages. There is currently no provision in the country’s laws to compensate victims of faulty devices, and CDSCO had initially only relied on assurances by the firm that it would provide compensation. If it is able to enforce this compensation, this might set a precedent for similar cases of patients seeking competition for faulty implants.
The company had approached the Delhi High Court in December 2018 asking that the compensation formula be quashed and that the court direct the government not to take any coercive steps against it. It had also asked court to set aside “all actions” arising from the report submitted by the expert committee, set up in 2017 by Health Ministry, to investigate the link between the implants and health issues faced by patients.
The committee, headed by former Maulana Azad Medical College Dean Dr Arun Agarwal, had concluded that these implants were “faulty”, potentially toxic and unsafe for patients, and had recommended that they be compensated.
However, a group of over 70 patients affected by these hip implants earlier raised concerns about the formula approved by the government, stating that it suffered from “ambiguities, deficiencies and lacunae”. This includes lack of clarity with compensation for any deaths that have occurred as a result of the implants.
“Our concerns remain, particularly since the (compensation) committee has not responded and we are not privy to the mechanism implemented in this case,” said Malini Aisola, who was part of the submission made by the group, known as the Hip Implant Patients Support Group (HIPS).
Johnson & Johnson had marketed the ASR (articular surface replacement) implants in India through its subsidiary DePuy between 2004 and 2010.
Following a UK study that showed that these implants had a higher failure rate, Johnson & Johnson initiated a global recall of the product in 2010.