New Delhi: In a major breakthrough for patients in the Johnson and Johnson Pvt. Ltd’s faulty hip implants case, India’s drug regulator has ordered the company to pay ₹74.6 lakh to an unidentified Mumbai-based patient.
The move comes months after a Mint investigation brought to light the plight of the patients who had suffered due to the faulty implant.
On 8 March, the government approved the recommendation of the central expert committee, which had examined and said the patient implanted with the “faulty" hip implant on both hips is entitled for the financial compensation as per the government-approved formula. The patient had also undergone a revision surgery in his left hip.
“As per the formula, the central expert committee has recommended for payment compensation of ₹74,57,180 to the patient," said the order. Mint has reviewed the copy of the order.
On 29 November, the centre had approved the formula devised by a government experts panel, which determined the quantum of compensation so that patients could secure the compensation amount from the company. The formula is based on the percentage of disability, age factor and risk factor. The compensation varies from ₹30 lakh to ₹1.2 crore.
The central expert committee under Dr R.K. Arya, director sports injury centre, Safdarjung Hospital, had examined the documents, including the disability certificates issued by the medical authority of Maharashtra, to decide on the compensation. The decision was subsequently backed by the recommendation of a state (Maharashtra) level committee.
Based on the recommendations of the central expert committee and the state-level committee, Central Drugs Standard Control Organisation (CDSCO) on Friday directed the company to pay ₹74.6 lakh within a period of 30 days from the date of receipt of the order as compensation to the patient, and submit a copy of the acknowledgment.
When contacted, J&J declined to comment, saying that the matter is sub judice.
In December, the pharma major had moved the Delhi high court against the government’s orders to compensate patients. However, the Supreme Court had, in a separate plea, had accepted the government’s recommendation, including the compensation amount, and had disposed of the matter.
Murali Neelakantan, an expert in healthcare laws, said that he would expect J&J to challenge the order. “Since the government order does not say if J&J has any opportunity to present its defence, J&J will make this its first ground for challenge. The court may ask the committee to give J&J the opportunity."
J&J has been criticized for failing to pay any compensation in India so far, although it had agreed to pay hefty damages of $2.5 billion to around 8,000 US citizens, who sued the company after receiving the faulty hip implants.
Incidentally, J&J recently restructured its Indian management with the company’s managing director for India Sushobhan Dasgupta moving to Singapore as vice president for orthopaedics, Asia Pacific. Raghavendra Shenoy, who was J&J’s general manager in Taiwan, has succeeded Dasgupta.
Dasgupta now serves both the orthopaedics global leadership team and the Asia Pacific medical devices leadership team. “As the regional leader, Sushobhan will continue to support key orthopaedic matters in India, including ASR (articular surface replacements)," the spokesperson said.
Around 4,700 ASR surgeries were carried out in India between 2004 and 2010. However, only 1,080 patients could be traced through the ASR helpline.
The implant, DePuy ASR, was sold in India by DePuy International, a J&J unit, has come under severe scrutiny of government agencies after a Mint investigation published on 23 August brought out the ordeal of patients and highlighted the negligence of the American company.
In 2017, the government had formed a panel headed by Dr. Arun Agarwal, former dean of Maulana Azad Medical College, which suggested compensation for each patient. Viewing that revision surgeries were necessitated due to the “faulty ASR", the committee had recommended that J&J be made liable to pay “adequate" compensation “commensurate with severity of the pain, the resultant disability, sufferings (both mental and physical) and with loss of wages of each patient who received Acetabular Surface Replacement (ASR)".